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    Clinical Trial Results:
    A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension

    Summary
    EudraCT number
    2015-003631-34
    Trial protocol
    BE   ES   CZ   FR   DK   IT  
    Global end of trial date
    26 Jan 2021

    Results information
    Results version number
    v2(current)
    This version publication date
    23 Mar 2022
    First version publication date
    10 Feb 2022
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Edit a footnote to a table.

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    192024-095
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02636946
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Allergan Limited
    Sponsor organisation address
    Marlow International The Parkway, Marlow Buckinghamshire, United Kingdom, SL7 1YL
    Public contact
    Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jan 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Feb 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    Thailand: 2
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    Poland: 8
    Country: Number of subjects enrolled
    Russian Federation: 6
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United States: 115
    Country: Number of subjects enrolled
    France: 3
    Worldwide total number of subjects
    144
    EEA total number of subjects
    18
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    91
    From 65 to 84 years
    53
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 144 participants were randomised with 72 participants in each treatment group. Out of them 142 participants were treated. The primary eye was defined as the eye with the higher intraocular pressure (IOP) at Baseline. If both the eyes were the same, the right eye was used as the primary eye. The contralateral eye is the other eye.

    Period 1
    Period 1 title
    Cycle 1 (Day 1 to Week 15)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind [1]
    Roles blinded
    Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Arm description
    Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
    Arm type
    Active comparator

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Sham Bimatoprost SR: Applicator Without Needle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in needle-free injector
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Sham Bimatoprost SR [applicator without needle] administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Selective Laser Trabeculoplasty administered on Day 1.

    Investigational medicinal product name
    Sham Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Sham Selective Laser Trabeculoplasty administered on Day 1.

    Arm title
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Arm description
    Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Sham Bimatoprost SR: Applicator Without Needle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in needle-free injector
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Sham Bimatoprost SR [applicator without needle] administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Selective Laser Trabeculoplasty administered on Day 1.

    Investigational medicinal product name
    Sham Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Sham Selective Laser Trabeculoplasty administered on Day 1.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: The investigator was not blinded.
    Number of subjects in period 1
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Started
    72
    72
    Received Treatment in Either Eye
    72
    70
    Completed
    71
    67
    Not completed
    1
    5
         Withdrawal of Consent
    -
    1
         Randomized but not Treated
    -
    2
         Protocol Violation
    -
    1
         Lost to follow-up
    1
    -
         Reason not Specified
    -
    1
    Period 2
    Period 2 title
    Cycle 2 (Week 16 to Week 31)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind [2]
    Roles blinded
    Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Arm description
    Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
    Arm type
    Active comparator

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Sham Bimatoprost SR: Applicator Without Needle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in needle-free injector
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Sham Bimatoprost SR [applicator without needle] administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Selective Laser Trabeculoplasty administered on Day 1.

    Investigational medicinal product name
    Sham Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Sham Selective Laser Trabeculoplasty administered on Day 1.

    Arm title
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Arm description
    Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Sham Bimatoprost SR: Applicator Without Needle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in needle-free injector
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Sham Bimatoprost SR [applicator without needle] administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Selective Laser Trabeculoplasty administered on Day 1.

    Investigational medicinal product name
    Sham Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Sham Selective Laser Trabeculoplasty administered on Day 1.

    Notes
    [2] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: The investigator was not blinded.
    Number of subjects in period 2 [3]
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Started
    65
    62
    Completed
    63
    61
    Not completed
    2
    1
         Adverse Event
    2
    1
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Started=received administration (Sham or Bimatoprost SR) in the cycle
    Period 3
    Period 3 title
    Cycle 3 (Week 32 to Week 52)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind [4]
    Roles blinded
    Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Arm description
    Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.
    Arm type
    Active comparator

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Sham Bimatoprost SR: Applicator Without Needle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in needle-free injector
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Sham Bimatoprost SR [applicator without needle] administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Selective Laser Trabeculoplasty administered on Day 1.

    Investigational medicinal product name
    Sham Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Sham Selective Laser Trabeculoplasty administered on Day 1.

    Arm title
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Arm description
    Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
    Arm type
    Experimental

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant in pre-filled syringe
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Sham Bimatoprost SR: Applicator Without Needle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in needle-free injector
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Up to three Sham Bimatoprost SR [applicator without needle] administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

    Investigational medicinal product name
    Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Selective Laser Trabeculoplasty administered on Day 1.

    Investigational medicinal product name
    Sham Selective Laser Trabeculoplasty
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Pharmaceutical dose form not applicable
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Sham Selective Laser Trabeculoplasty administered on Day 1.

    Notes
    [4] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: The investigator was not blinded.
    Number of subjects in period 3 [5]
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Started
    17
    16
    Completed
    17
    16
    Notes
    [5] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Started=received administration (Sham or Bimatoprost SR) in the cycle

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Reporting group description
    Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.

    Reporting group title
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Reporting group description
    Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.

    Reporting group values
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Total
    Number of subjects
    72 72 144
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    53 38 91
        From 65-84 years
    19 34 53
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    57.9 ± 10.2 62.1 ± 11.4 -
    Gender categorical
    Units: Subjects
        Female
    28 39 67
        Male
    44 33 77
    Race
    Units: Subjects
        White
    53 59 112
        Black or African American
    12 9 21
        Asian
    5 3 8
        Not Reported
    2 1 3
    Ethnicity
    Units: Subjects
        Hispanic
    11 7 18
        Non-Hispanic
    61 64 125
        Not Reported
    0 1 1

    End points

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    End points reporting groups
    Reporting group title
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Reporting group description
    Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.

    Reporting group title
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Reporting group description
    Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
    Reporting group title
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Reporting group description
    Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.

    Reporting group title
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Reporting group description
    Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.
    Reporting group title
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Reporting group description
    Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.

    Reporting group title
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Reporting group description
    Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.

    Subject analysis set title
    Selective Laser Trabeculoplasty
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    SLT administered on Day 1. Participants’ primary eyes from ‘SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)’ arm and contralateral eyes from ‘Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)’ arm were combined for outcome measure analyses.

    Subject analysis set title
    Bim SR 15 μg
    Subject analysis set type
    Modified intention-to-treat
    Subject analysis set description
    Three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Participants’ contralateral eyes from ‘SLT (Primary Eye) / Bim SR 15 ug (Contralateral Eye)’ arm and primary eyes from ‘Bim SR 15 ug (Primary Eye) / SLT (Contralateral Eye)’ arm were combined for outcome measure analyses.

    Primary: Change From Baseline in IOP at Week 4

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    End point title
    Change From Baseline in IOP at Week 4
    End point description
    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses. Modified Intent-to-Treat (mITT) Population was defined based in the Intent-to-Treat (ITT) population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analysed are number of participants and eyes with data available for analyses.
    End point type
    Primary
    End point timeframe
    Baseline (prior to treatment) to Week 4
    End point values
    Selective Laser Trabeculoplasty Bim SR 15 μg
    Number of subjects analysed
    131
    135
    Units: mmHg
        least squares mean (standard error)
    -6.28 ± 0.30
    -6.98 ± 0.29
    Statistical analysis title
    Change from Baseline at Week 4
    Statistical analysis description
    The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).
    Comparison groups
    Selective Laser Trabeculoplasty v Bim SR 15 μg
    Number of subjects included in analysis
    266
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    P-value
    = 0.0166
    Method
    MMRM
    Parameter type
    Least-squares Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.28
         upper limit
    -0.13
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Notes
    [1] - MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.

    Primary: Change From Baseline in IOP at Week 12

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    End point title
    Change From Baseline in IOP at Week 12
    End point description
    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analysed are number of participants and eyes with data available for analyses.
    End point type
    Primary
    End point timeframe
    Baseline (prior to treatment) to Week 12
    End point values
    Selective Laser Trabeculoplasty Bim SR 15 μg
    Number of subjects analysed
    122
    128
    Units: mmHg
        least squares mean (standard error)
    -6.28 ± 0.29
    -6.81 ± 0.29
    Statistical analysis title
    Change from Baseline at Week 12
    Statistical analysis description
    The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% CI was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).
    Comparison groups
    Selective Laser Trabeculoplasty v Bim SR 15 μg
    Number of subjects included in analysis
    250
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    P-value
    = 0.0735
    Method
    MMRM
    Parameter type
    Least-squares Mean Difference
    Point estimate
    -0.52
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.09
         upper limit
    0.05
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Notes
    [2] - MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.

    Primary: Change From Baseline in Intraocular Pressure (IOP) at Week 24

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    End point title
    Change From Baseline in Intraocular Pressure (IOP) at Week 24
    End point description
    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses. mITT Population was defined based in the ITT population but excluded participants who did not receive the second implant after implementation of Amendment 3. Overall number analyzed are number of participants and eyes with data available for analyses.
    End point type
    Primary
    End point timeframe
    Baseline (prior to treatment) to Week 24
    End point values
    Selective Laser Trabeculoplasty Bim SR 15 μg
    Number of subjects analysed
    117
    126
    Units: mmHg
        least squares mean (standard error)
    -6.34 ± 0.29
    -6.59 ± 0.29
    Statistical analysis title
    Change from Baseline at Week 24
    Statistical analysis description
    The null hypothesis was that bimatoprost SR 15 μg was to be declared non-inferior to SLT if the upper limit of the 95% confidence interval (CI) was ≤ 1.5 mmHg at all scheduled visits (Weeks 4, 12, and 24).
    Comparison groups
    Selective Laser Trabeculoplasty v Bim SR 15 μg
    Number of subjects included in analysis
    243
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    P-value
    = 0.3928
    Method
    MMRM
    Parameter type
    Least-squares Mean Difference
    Point estimate
    -0.25
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.81
         upper limit
    0.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.29
    Notes
    [3] - MMRM was used for IOP change from baseline. The model includes IOP change from baseline as the response variable and treatment, visit, eye, baseline IOP, treatment-by-baseline, treatment-by-eye, treatment-by-visit, visit-by-eye interactions as covariates. A Kronecker product of unstructured covariance matrix for study visit and compound symmetry covariance matrix for between eye correlation was used in the analysis.

    Secondary: Change From Baseline in IOP at Weeks 8, 15, and 20

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    End point title
    Change From Baseline in IOP at Weeks 8, 15, and 20
    End point description
    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. ITT Population was defined as all randomized participants. n=number analysed is the number of participants and eyes analysed at the given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to treatment) to Weeks 8, 15 and 20
    End point values
    Selective Laser Trabeculoplasty Bim SR 15 μg
    Number of subjects analysed
    144
    144
    Units: mmHg
    arithmetic mean (standard deviation)
        Change from Baseline at Week 8 (n= 133, 137)
    -6.65 ± 3.10
    -7.09 ± 2.93
        Change from Baseline at Week 15 (n= 126, 133)
    -6.14 ± 3.47
    -5.36 ± 3.73
        Change from Baseline at Week 20 (n= 8, 7)
    -5.06 ± 3.33
    -4.29 ± 1.93
    No statistical analyses for this end point

    Secondary: Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator

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    End point title
    Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator
    End point description
    Median time in days from first treatment to the initial use of non-study IOP-lowering treatment. ITT Population was defined as all randomized participants. Overall number analyzed are number of participants and eyes with data available for analyses. 99999 denotes the upper limit of 95% confidence interval was not estimable due to the low number of participants with events.
    End point type
    Secondary
    End point timeframe
    First treatment to end of study (up to 525 days)
    End point values
    Selective Laser Trabeculoplasty Bim SR 15 μg
    Number of subjects analysed
    142
    141
    Units: days
        median (confidence interval 95%)
    410 (392.0 to 99999)
    446 (407.0 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP

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    End point title
    Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP
    End point description
    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3. ITT Population was defined as all randomized participants. n=number analysed and is number of participants and eyes analysed at the given timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20
    End point values
    Selective Laser Trabeculoplasty Bim SR 15 μg
    Number of subjects analysed
    144
    144
    Units: percentage of participants
    number (not applicable)
        Cycle 1 Day 2 (n= 137, 137)
    60.6
    92.7
        Cycle 1 Week 4 (n= 141, 141)
    70.2
    78.0
        Cycle 1 Week 8 (n= 140, 140)
    72.9
    80.0
        Cycle 1 Week 12 (n= 137, 137)
    67.9
    75.2
        Cycle 1 Week 15 (n= 134, 134)
    67.2
    64.2
        Cycle 1 Week 20 (n= 10, 10)
    50.0
    40.0
        Cycle 1 Week 24 (n= 11, 11)
    81.8
    45.5
        Cycle 1 Week 28 (n= 11, 11)
    63.6
    45.5
        Cycle 1 Week 31 (n= 5, 5)
    100.0
    40.0
        Cycle 1 Week 36 (n= 11, 11)
    72.7
    72.7
        Cycle 1 Week 40 (n= 11, 11)
    54.5
    54.5
        Cycle 1 Week 44 (n= 11, 11)
    81.8
    45.5
        Cycle 1 Week 47 (n= 11, 11)
    72.7
    54.5
        Cycle 1 Week 52 (n= 11, 11)
    81.8
    81.8
        Cycle 2 Day 2 (n= 124, 124)
    70.2
    89.5
        Cycle 2 Week 4 (n= 125, 125)
    68.8
    75.2
        Cycle 2 Week 8 (n= 124, 124)
    68.5
    71.0
        Cycle 2 Week 12 (n= 118, 118)
    72.0
    65.3
        Cycle 2 Week 15 (n= 98, 98)
    69.4
    64.3
        Cycle 2 Week 20 (n= 91, 91)
    76.9
    64.8
        Cycle 2 Week 24 (n= 87, 87)
    64.4
    71.3
        Cycle 2 Week 28 (n= 85, 85)
    76.5
    74.1
        Cycle 2 Week 31 (n= 86, 86)
    76.7
    74.4
        Cycle 2 Week 36 (n= 91, 91)
    79.1
    67.0
        Cycle 3 Day 2 (n= 33, 33)
    75.8
    90.9
        Cycle 3 Week 4 (n= 31, 31)
    74.2
    71.0
        Cycle 3 Week 8 (n= 32, 32)
    75.0
    59.4
        Cycle 3 Week 15 (n= 30, 30)
    70.0
    43.3
        Cycle 3 Week 20 (n= 33, 33)
    69.7
    39.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First treatment to end of study (up to 525 days)
    Adverse event reporting additional description
    All-cause Mortality:ITT Population=all randomized participants.Serious/Other AEs:Safety Population=all treated participants;data collected,presented as randomized.Ocular AEs(Eye Disorders)collected and reported for each eye(primary/contralateral)separately.AE footnotes=number of AEs in primary and contralateral eye.A participant could have≥1events.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
    Reporting group description
    Primary Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later.

    Reporting group title
    SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Reporting group description
    Primary Eye: Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to three Sham Bimatoprost sustained release (Bim SR) administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Sham Bimatoprost SR administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants who were enrolled under Protocol Amendment 2 or later. Contralateral (Other) Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1), Weeks 16 (Cycle 2) and 32 (Cycle 3) or two Bimatoprost SR 15 μg administrations at Day 4 (Cycle 1) and Week 16 (Cycle 2) for participants enrolled under Protocol Amendment 2 or later.

    Serious adverse events
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 70 (8.57%)
    11 / 72 (15.28%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Quadrantanopia
    Additional description: 1 adverse event occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=0, Contralateral Eye=1).
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Corneal endothelial cell loss
    Additional description: 4 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=0, Contralateral Eye=4); 1 adverse event occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=1, Contralateral Eye=0).
         subjects affected / exposed
    1 / 70 (1.43%)
    4 / 72 (5.56%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
    Additional description: 1 adverse event occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=0, Contralateral Eye=1).
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal oedema
    Additional description: 2 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=2, Contralateral Eye=0).
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 72 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 70 (62.86%)
    56 / 72 (77.78%)
    Investigations
    Intraocular pressure increased
    Additional description: 18 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=8, Contralateral Eye=10);12 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=6, Contralateral Eye=6).
         subjects affected / exposed
    7 / 70 (10.00%)
    13 / 72 (18.06%)
         occurrences all number
    13
    21
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 70 (8.57%)
    2 / 72 (2.78%)
         occurrences all number
    6
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 70 (5.71%)
    3 / 72 (4.17%)
         occurrences all number
    5
    5
    Eye disorders
    Conjunctival hyperaemia
    Additional description: 48 adverse events occurred in SLT (Primary Eye)/Bim SR 15 µg (Contralateral Eye) Arm:(Primary Eye=20,Contralateral Eye=28);27 adverse events occurred in Bim SR 15 µg(Primary Eye)/SLT (Contralateral Eye) Arm (Primary Eye=19, Contralateral Eye=8).
         subjects affected / exposed
    19 / 70 (27.14%)
    30 / 72 (41.67%)
         occurrences all number
    36
    79
    Corneal endothelial cell loss
    Additional description: 11 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=10); 4 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=3, Contralateral Eye=1).
         subjects affected / exposed
    4 / 70 (5.71%)
    11 / 72 (15.28%)
         occurrences all number
    4
    12
    Punctate keratitis
    Additional description: 18 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=8, Contralateral Eye=10);14 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=8, Contralateral Eye=6).
         subjects affected / exposed
    8 / 70 (11.43%)
    10 / 72 (13.89%)
         occurrences all number
    21
    20
    Conjunctival haemorrhage
    Additional description: 8 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=7); 7 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=5, Contralateral Eye=2).
         subjects affected / exposed
    5 / 70 (7.14%)
    7 / 72 (9.72%)
         occurrences all number
    9
    9
    Corneal oedema
    Additional description: 6 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=5); 9 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=8, Contralateral Eye=1).
         subjects affected / exposed
    9 / 70 (12.86%)
    6 / 72 (8.33%)
         occurrences all number
    9
    7
    Photophobia
    Additional description: 8 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=2, Contralateral Eye=6); 6 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=4, Contralateral Eye=2).
         subjects affected / exposed
    4 / 70 (5.71%)
    6 / 72 (8.33%)
         occurrences all number
    10
    12
    Eye irritation
    Additional description: 10 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=4, Contralateral Eye=6); 5 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=3, Contralateral Eye=2).
         subjects affected / exposed
    3 / 70 (4.29%)
    6 / 72 (8.33%)
         occurrences all number
    7
    14
    Eye pain
    Additional description: 6 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=4, Contralateral Eye=2); 10 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=7, Contralateral Eye=3).
         subjects affected / exposed
    9 / 70 (12.86%)
    5 / 72 (6.94%)
         occurrences all number
    11
    6
    Dry eye
    Additional description: 8 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=4, Contralateral Eye=4); 4 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=3, Contralateral Eye=1).
         subjects affected / exposed
    3 / 70 (4.29%)
    5 / 72 (6.94%)
         occurrences all number
    4
    11
    Anterior chamber cell
    Additional description: 5 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=4); 3 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=2, Contralateral Eye=1).
         subjects affected / exposed
    3 / 70 (4.29%)
    4 / 72 (5.56%)
         occurrences all number
    3
    6
    Foreign body sensation in eyes
    Additional description: 5 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=4); 3 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=3, Contralateral Eye=0).
         subjects affected / exposed
    3 / 70 (4.29%)
    4 / 72 (5.56%)
         occurrences all number
    3
    6
    Corneal opacity
    Additional description: 4 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=1, Contralateral Eye=3).
         subjects affected / exposed
    0 / 70 (0.00%)
    4 / 72 (5.56%)
         occurrences all number
    0
    4
    Infections and infestations
    Conjunctivitis
    Additional description: 4 adverse events occurred in SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye) Arm: (Primary Eye=0, Contralateral Eye=4); 2 adverse events occurred in Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye) Arm (Primary Eye=1, Contralateral Eye=1).
         subjects affected / exposed
    1 / 70 (1.43%)
    4 / 72 (5.56%)
         occurrences all number
    2
    5
    Sinusitis
         subjects affected / exposed
    4 / 70 (5.71%)
    1 / 72 (1.39%)
         occurrences all number
    6
    1
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    4 / 70 (5.71%)
    0 / 72 (0.00%)
         occurrences all number
    4
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Apr 2017
    The following changes were implemented with Amendment 1: Changed requirement for additional biomicroscopy and IOP measurements on Day 1 for participants with sickle-cell disease to be optional. Updated study status. Updated information from completed studies. Updated the approximate number of sites. Modified the eligibility criteria. For clarification purposes, revised to use generic terminology rather than brand names, which may not be identical in all study locations. Revised storage conditions of the product. Corrected errors in the original protocol. Visit window text was revised for clarification. Reordered some study procedures and clarified which procedures must be performed in the order shown to provide additional flexibility to sites and participants.
    28 Sep 2018
    The following changes were implemented with Amendment 2: Reduced the number of administration cycles from 3 to 2. Added new schedule for all participants for Week 36 through Week 52/Exit and removed these visits from the schedule for the third treatment cycle. Specified number of administration cycles for participants enrolled in each stage. Specified that visits associated with the third treatment cycle are for participants who reached Week 32 prior to implementation of Amendment 2 only. Extended safety follow-up period for participants who received nonstudy IOP-lowering medication in both eyes or did not complete an administration visit. Specified analysis populations, and analyses for Stages 1 and 2. Increased sample size so that approximately 160 participants would be enrolled in the study.
    27 Mar 2020
    The following changes were implemented with Amendment 3: Updated the protocol to reflect that participants who were enrolled and had not yet reached Week 16 would not receive Cycle 2 administration and no additional administrations of the Bimatoprost SR 15 μg dose would be given. Therefore, the Week 16 would not be required for these participants and they would continue to be followed at the scheduled follow-up visits through Week 52/Exit. Revised statistical methods. Added Rho-kinase inhibitors to the list of medications requiring washout.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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