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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
    		 2015-002131-18
    Trial protocol
    		 GB   DE   DK   PL   FR  
    Global end of trial date
    31 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2024
    First version publication date
    03 Apr 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    192024-093
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02507687
    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, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 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
    31 May 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients 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
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 Procedure/Surgery: Selective Laser Trabeculoplasty SLT is a laser procedure that targets the pigment in specific cells of the eye. An ophthalmologist performed 360 degrees of SLT using a standardized method. Procedure/Surgery: Sham Selective Laser Trabeculoplasty Sham SLT is performed on the contralateral eye using the same method as for SLT, with the exception that the laser is not switched to the active state.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Aug 2015
    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
    Australia: 20
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Denmark: 1
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    New Zealand: 12
    Country: Number of subjects enrolled
    Philippines: 8
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    United States: 165
    Worldwide total number of subjects
    240
    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)
    128
    From 65 to 84 years
    109
    85 years and over
    3

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were randomized at 61 sites in 11 countries (Australia, Canada, Germany, Denmark, France, Great Britain, Israel, New Zealand, Philippines, Poland, and the US). The eye with the higher IOP at Baseline was assigned as the primary (PR) eye. If Baseline IOP was the same in both eyes, the right eye was the PR eye.

    Pre-assignment
    Screening details
    		 The PR eye was randomized to receive bimatoprost SR or SLT using a 1:1 ratio. If the PR eye received bimatoprost SR, the contralateral (CL) eye received SLT. If the PR eye received SLT, the CL eye received bimatoprost SR.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Carer, Assessor
    Blinding implementation details
    Prior to initiation of any study procedures, each subject was assigned a number that served as the subject’s identification number on all study documents. For determination of stratification group assignment for the PR eye for each subject, sites were required to enter Baseline IOP (at Hour 0) data for both eyes into an automated interactive response system.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Stage 1: SLT (PR Eye)/Bimatoprost SR 15 μg (CL Eye)
    Arm description
    		 Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. CL Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracameral use
    Dosage and administration details
    Bimatoprost SR is a biodegradable, sustained-release, preservative free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is administered into the anterior chamber via the corneal limbus using the prefilled applicator.

    Investigational medicinal product name
    Sham Bimatoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracameral use
    Dosage and administration details
    Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.

    Arm title
    		 Stage 1: Bimatoprost SR 15 μg (PR Eye) / SLT (CL Eye)
    Arm description
    		 Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. CL Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracameral use
    Dosage and administration details
    Bimatoprost SR is a biodegradable, sustained-release, preservative free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is administered into the anterior chamber via the corneal limbus using the prefilled applicator.

    Investigational medicinal product name
    Sham Bimatoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracameral use
    Dosage and administration details
    Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.

    Arm title
    		 Stage 2: SLT (PR Eye) / Bimatoprost SR 10 μg (CL Eye)
    Arm description
    		 Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. CL Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracameral use
    Dosage and administration details
    Bimatoprost SR is a biodegradable, sustained-release, preservative free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is administered into the anterior chamber via the corneal limbus using the prefilled applicator.

    Investigational medicinal product name
    Sham Bimatoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracameral use
    Dosage and administration details
    Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.

    Arm title
    		 Stage 2: Bimatoprost SR 10 μg (PR Eye) / SLT (CL Eye)
    Arm description
    		 Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. CL Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimatoprost SR
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracameral use
    Dosage and administration details
    Bimatoprost SR is a biodegradable, sustained-release, preservative free bimatoprost implant, preloaded in an applicator for administration. The Bimatoprost SR implant is administered into the anterior chamber via the corneal limbus using the prefilled applicator.

    Investigational medicinal product name
    Sham Bimatoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Implant
    Routes of administration
    Intracameral use
    Dosage and administration details
    Sham bimatoprost SR performed using the same procedure as for Bimatoprost SR using an needleless applicator that touches the eye at the area of insertion but does not deliver an implant into the anterior chamber.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: The correct roles blinded are specified.
    Number of subjects in period 1
    		Stage 1: SLT (PR Eye)/Bimatoprost SR 15 μg (CL Eye) Stage 1: Bimatoprost SR 15 μg (PR Eye) / SLT (CL Eye) Stage 2: SLT (PR Eye) / Bimatoprost SR 10 μg (CL Eye) Stage 2: Bimatoprost SR 10 μg (PR Eye) / SLT (CL Eye)
    Started
    29
    28
    92
    91
    Received Treatment
    29
    27
    90
    90
    Completed
    24
    22
    77
    78
    Not completed
    5
    6
    15
    13
         Consent withdrawn by subject
    1
    4
    6
    6
         Other, not specified
    -
    -
    2
    4
         Adverse event
    3
    2
    2
    2
         Screen failure
    -
    -
    1
    -
         Lost to follow-up
    -
    -
    2
    1
         Protocol deviation
    1
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Stage 1: SLT (PR Eye)/Bimatoprost SR 15 μg (CL Eye)
    Reporting group description
    		 Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. CL Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).

    Reporting group title
    Stage 1: Bimatoprost SR 15 μg (PR Eye) / SLT (CL Eye)
    Reporting group description
    		 Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. CL Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).

    Reporting group title
    Stage 2: SLT (PR Eye) / Bimatoprost SR 10 μg (CL Eye)
    Reporting group description
    		 Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. CL Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met.

    Reporting group title
    Stage 2: Bimatoprost SR 10 μg (PR Eye) / SLT (CL Eye)
    Reporting group description
    		 Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. CL Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met.

    Reporting group values
    		 Stage 1: SLT (PR Eye)/Bimatoprost SR 15 μg (CL Eye) Stage 1: Bimatoprost SR 15 μg (PR Eye) / SLT (CL Eye) Stage 2: SLT (PR Eye) / Bimatoprost SR 10 μg (CL Eye) Stage 2: Bimatoprost SR 10 μg (PR Eye) / SLT (CL Eye) Total
    Number of subjects
    		 29 28 92 91 240
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.9 ± 12.32 59.6 ± 13.59 62.6 ± 11.61 62.1 ± 10.74 -
    Gender categorical
    Units: Subjects
        Female
    		 16 12 46 48 122
        Male
    		 13 16 46 43 118
    Race
    Units: Subjects
        White
    		 25 23 58 69 175
        Black or African American
    		 1 2 27 14 44
        Asian
    		 3 3 4 6 16
        American Indian or Alaska Native
    		 0 0 0 2 2
        Not Reported
    		 0 0 3 0 3
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 4 6 10 21
        Not Hispanic or Latino
    		 28 24 86 81 219
        Unknown or Not Reported
    		 0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Stage 1: SLT (PR Eye)/Bimatoprost SR 15 μg (CL Eye)
    Reporting group description
    		 Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. CL Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).

    Reporting group title
    Stage 1: Bimatoprost SR 15 μg (PR Eye) / SLT (CL Eye)
    Reporting group description
    		 Participants enrolled prior to implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. CL Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).

    Reporting group title
    Stage 2: SLT (PR Eye) / Bimatoprost SR 10 μg (CL Eye)
    Reporting group description
    		 Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. CL Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met.

    Reporting group title
    Stage 2: Bimatoprost SR 10 μg (PR Eye) / SLT (CL Eye)
    Reporting group description
    		 Participants enrolled after implementation of Protocol Amendment 3 received the following treatment in each eye: Assigned PR Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. CL Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met.

    Subject analysis set title
    Stage 2: SLT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    One 360° administration of SLT on Day 1 followed by up to two sham bimatoprost SR administrations.

    Subject analysis set title
    Stage 2: Bimatoprost SR 10 μg
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Sham SLT on Day 1 followed by bimatoprost SR 10 μg administered on Day 4 with repeat administration at Week 16 or after Week 16 and prior to Month 12 depending on when retreatment criteria were met.

    Primary: Change From Baseline in Intraocular Pressure at Week 4

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    End point title
    		 Change From Baseline in Intraocular Pressure at Week 4 [1]
    End point description
    Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. A mixed-effects model with repeated measures (MMRM) was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. The intent-to-treat (ITT) population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis.
    End point type
    Primary
    End point timeframe
    Baseline and Week 4
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 Stage 2: SLT Stage 2: Bimatoprost SR 10 μg
    Number of subjects analysed
    168 [2]
    170 [3]
    Units: mmHg
        least squares mean (standard error)
    -6.2 ± 0.28
    -6.8 ± 0.28
    Attachments
    		 Untitled (Filename: Statistical Analysis Week 4.docx)
    Notes
    [2] - 168 eyes
    [3] - 170 eyes
    No statistical analyses for this end point

    Primary: Change From Baseline in Intraocular Pressure at Week 12

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    End point title
    		 Change From Baseline in Intraocular Pressure at Week 12 [4]
    End point description
    Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. The ITT population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 Stage 2: SLT Stage 2: Bimatoprost SR 10 μg
    Number of subjects analysed
    149 [5]
    156 [6]
    Units: mmHg
        least squares mean (standard error)
    -6.4 ± 0.30
    -6.9 ± 0.30
    Attachments
    		 Untitled (Filename: Statistical Analysis Week 12.docx)
    Notes
    [5] - 149 eyes
    [6] - 156 eyes
    No statistical analyses for this end point

    Primary: Change From Baseline in Intraocular Pressure at Week 24

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    End point title
    		 Change From Baseline in Intraocular Pressure at Week 24 [7]
    End point description
    Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. An MMRM was used for the analysis. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. The ITT population is defined as all randomized participants. Primary efficacy analysis was performed for participants enrolled in Stage 2. Overall Number of Participants / Units Analyzed reflects the number of participants and eyes with data available for the analysis.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are presented per protocol.
    End point values
    		 Stage 2: SLT Stage 2: Bimatoprost SR 10 μg
    Number of subjects analysed
    138 [8]
    145 [9]
    Units: mmHg
        least squares mean (standard error)
    -6.5 ± 0.28
    -6.9 ± 0.27
    Attachments
    		 Untitled (Filename: Statistical Analysis Week 24.docx)
    Notes
    [8] - 138 eyes
    [9] - 145 eyes
    No statistical analyses for this end point

    Secondary: Time to Initial Use of Non-study IOP-lowering Treatment

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    End point title
    		 Time to Initial Use of Non-study IOP-lowering Treatment
    End point description
    The time from the date of initial treatment to the date date of first use of non-study IOP-lowering treatment (rescue) was analyzed using the Kaplan-Meier method. If a participant did not use any non-study IOP-lowering treatment in an eye, then the event (initial use of non-study IOP lowering treatment) time was censored at the study exit date or the last visit date if the study exit date was not available. Participants in the ITT population enrolled in Stage 2; eyes that received study treatment are included in the analysis.
    End point type
    Secondary
    End point timeframe
    From first administration of study treatment to the end of study; overall median follow-up time of 728 days.
    End point values
    		 Stage 2: SLT Stage 2: Bimatoprost SR 10 μg
    Number of subjects analysed
    180 [10]
    175 [11]
    Units: days
    median (confidence interval 95%)
        25% percentile
    263 (167.0 to 329.0)
    276 (217.0 to 323.0)
        50% percentile
    99999 (736.0 to 99999)
    732 (496.0 to 99999)
        75% percentile
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    Notes
    [10] - 180 eyes 99999=NA (Data could not be estimated due to the low number of events.)
    [11] - 175 eyes 99999=NA (Data could not be estimated due to the low number of events.)
    No statistical analyses for this end point

    Secondary: Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle

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    End point title
    		 Percentage of Eyes Achieving ≥ 20% Reduction in IOP From Baseline Regardless of Cycle
    End point description
    Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. For by-cycle analyses, cycle number refers to the administration cycle for bimatoprost SR, or sham bimatoprost SR administration in SLT-treated eyes. For SLT-treated eyes cycle number does not refer to SLT administrations, because SLT was only performed once (Day 1). The Day/Week number refers to the number of days/weeks after bimatoprost SR/sham bimatoprost SR administration. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. Participants/eyes enrolled in Stage 2 with available IOP data at Baseline and each time point; participants who received retreatment with bimatoprost SR/sham bimatoprost SR at or after Week 16 are not included in Cycle 1 time points from the date of retreatment.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52, Months 13, 14, 15, 16, 18, 20, 22, 24
    End point values
    		 Stage 2: SLT Stage 2: Bimatoprost SR 10 μg
    Number of subjects analysed
    183 [12]
    183 [13]
    Units: percentage of eyes
    number (not applicable)
        Day 2; n=171, 172
    59.1
    86.6
        Week 4; n=168, 170
    68.5
    71.2
        Week 8; n=164, 166
    64.0
    75.3
        Week 12; n=149, 156
    71.1
    71.8
        Week 15; n=147, 152
    65.3
    61.2
        Week 20; n=145, 150
    62.8
    67.3
        Week 24; n=138, 145
    73.2
    75.2
        Week 28; n=129, 133
    72.1
    71.4
        Week 31; n=126, 132
    67.5
    62.1
        Week 36; n=126, 128
    68.3
    55.5
        Week 40; n=122, 121
    72.1
    62.0
        Week 44; n=116, 114
    65.5
    57.9
        Week 47; n=114, 110
    83.3
    70.9
        Week 52; n=111, 110
    78.4
    66.4
        Month 13; n=78, 70
    73.1
    65.7
        Month 14; n=79, 72
    73.4
    56.9
        Month 15; n=75, 67
    72.0
    61.2
        Month 16; n=82, 72
    76.8
    70.8
        Month 18; n=72, 63
    75.0
    60.3
        Month 20; n=73, 61
    79.5
    62.3
        Month 22; n=70, 55
    78.6
    69.1
        Month 24; n=71, 57
    73.2
    66.7
    Notes
    [12] - n=number of eyes at given time point
    [13] - n=number of eyes at given time point
    No statistical analyses for this end point

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

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    End point title
    		 Change From Baseline in Intraocular Pressure at Weeks 8, 15, and 20
    End point description
    Intraocular pressure was measured at 8 am (Hour 0) at each visit in each eye using the Goldmann applanation tonometer. A negative change from Baseline indicates a decrease (improvement) in intraocular pressure. IOP measurements obtained after initiation of non-study IOP-lowering treatment in an eye were excluded from the analysis. Intent-to-treat poulation participants enrolled in Stage 2 with available IOP data at each time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 8, 15, and 20
    End point values
    		 Stage 2: SLT Stage 2: Bimatoprost SR 10 μg
    Number of subjects analysed
    183
    183
    Units: mmHg
    arithmetic mean (standard deviation)
        Baseline; n=183, 183 eyes/subjects
    25.1 ± 3.00
    25.2 ± 2.99
        Week 8; n=164, 166 eyes/subjects
    -6.1 ± 3.52
    -6.8 ± 3.96
        Week 15; n=147, 152 eyes/subjects
    -6.0 ± 3.58
    -6.0 ± 4.36
        Week 20; n=145, 150 eyes/subjects
    -5.9 ± 3.44
    -6.4 ± 3.97
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to Month 24 ±7 days. Six participants who started treatment received SLT only (1 participant had a planned Stage 1 treatment of Bimatoprost SR 15 µg; 5 participants had a planned Stage 2 treatment of Bimatoprost SR 10 µg.)
    Adverse event reporting additional description
    Ocular AEs (i.e., those reported for the system organ class 'eye disorders' plus those footnoted as 'ocular events') are reported for the eye that received the treatment specified. Because this is a paired-eye study, and both eyes belong to a single participant, non-ocular AEs affect both reporting groups, and are reported under both interventions.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Stage 1: SLT
    Reporting group description
    		 Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).

    Reporting group title
    Stage 1: Bimatoprost SR 15 μg
    Reporting group description
    		 Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 μg administrations. Bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reached Week 32 prior to implementation of Protocol Amendment 3 only).

    Reporting group title
    Stage 2: SLT
    Reporting group description
    		 SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Sham bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met.

    Reporting group title
    Stage 2: Bimatoprost SR 10 μg
    Reporting group description
    		 Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 μg administrations. Bimatoprost SR was administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could have occurred after Week 16 and prior to Month 12 based on when retreatment criteria were met.

    Serious adverse events
    		 Stage 1: SLT Stage 1: Bimatoprost SR 15 μg Stage 2: SLT Stage 2: Bimatoprost SR 10 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    18 / 180 (10.00%)
    22 / 175 (12.57%)
         number of deaths (all causes)
    0
    0
    2
    2
         number of deaths resulting from adverse events
    0
    0
    2
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    GASTRIC CANCER
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    BLADDER CANCER
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    ADENOCARCINOMA OF COLON
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OESOPHAGEAL CANCER METASTATIC
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    PROSTATE CANCER
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PROSTATE CANCER STAGE I
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RENAL CELL CARCINOMA
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    ACCELERATED HYPERTENSION
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPERTENSION
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ARTERIOSCLEROSIS CORONARY ARTERY
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    0 / 180 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CARDIAC FAILURE CONGESTIVE
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    2 / 180 (1.11%)
    2 / 175 (1.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    MYELOPATHY
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    APHASIA
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    EPISCLERITIS
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 180 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PHOTOPHOBIA
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 180 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RETINAL VEIN OCCLUSION
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 55 (0.00%)
    0 / 180 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VISION BLURRED
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 180 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CORNEAL THICKENING
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 180 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CATARACT SUBCAPSULAR
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 180 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CORNEAL OEDEMA
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 55 (1.82%)
    0 / 180 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CORNEAL ENDOTHELIAL CELL LOSS
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    0 / 180 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    VOCAL CORD DISORDER
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    SKIN ULCER
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SPINAL OSTEOARTHRITIS
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    OSTEOARTHRITIS
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MUSCULAR WEAKNESS
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CERVICAL SPINAL STENOSIS
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 55 (1.82%)
    0 / 180 (0.00%)
    0 / 175 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    BURSITIS INFECTIVE
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Stage 1: SLT Stage 1: Bimatoprost SR 15 μg Stage 2: SLT Stage 2: Bimatoprost SR 10 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 56 (73.21%)
    49 / 55 (89.09%)
    107 / 180 (59.44%)
    121 / 175 (69.14%)
    Investigations
    INTRAOCULAR PRESSURE INCREASED
    Additional description: ocular event
         subjects affected / exposed
    5 / 56 (8.93%)
    8 / 55 (14.55%)
    33 / 180 (18.33%)
    43 / 175 (24.57%)
         occurrences all number
    6
    8
    41
    55
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 55 (7.27%)
    15 / 180 (8.33%)
    15 / 175 (8.57%)
         occurrences all number
    4
    4
    16
    16
    Nervous system disorders
    HEADACHE
    Additional description: Stage 1 arms = ocular event
         subjects affected / exposed
    1 / 56 (1.79%)
    2 / 55 (3.64%)
    10 / 180 (5.56%)
    10 / 175 (5.71%)
         occurrences all number
    1
    2
    10
    10
    Eye disorders
    ANTERIOR CHAMBER CELL
         subjects affected / exposed
    4 / 56 (7.14%)
    6 / 55 (10.91%)
    10 / 180 (5.56%)
    7 / 175 (4.00%)
         occurrences all number
    4
    8
    10
    12
    CONJUNCTIVAL HAEMORRHAGE
         subjects affected / exposed
    6 / 56 (10.71%)
    10 / 55 (18.18%)
    2 / 180 (1.11%)
    9 / 175 (5.14%)
         occurrences all number
    6
    11
    2
    9
    BLEPHARITIS
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 55 (3.64%)
    4 / 180 (2.22%)
    3 / 175 (1.71%)
         occurrences all number
    3
    2
    4
    3
    ANTERIOR CHAMBER FLARE
         subjects affected / exposed
    2 / 56 (3.57%)
    4 / 55 (7.27%)
    1 / 180 (0.56%)
    3 / 175 (1.71%)
         occurrences all number
    2
    4
    1
    4
    EYE IRRITATION
         subjects affected / exposed
    4 / 56 (7.14%)
    6 / 55 (10.91%)
    2 / 180 (1.11%)
    4 / 175 (2.29%)
         occurrences all number
    4
    6
    2
    4
    EYE PAIN
         subjects affected / exposed
    6 / 56 (10.71%)
    6 / 55 (10.91%)
    4 / 180 (2.22%)
    15 / 175 (8.57%)
         occurrences all number
    7
    11
    5
    19
    FOREIGN BODY SENSATION IN EYES
         subjects affected / exposed
    1 / 56 (1.79%)
    5 / 55 (9.09%)
    2 / 180 (1.11%)
    12 / 175 (6.86%)
         occurrences all number
    1
    5
    2
    14
    IRITIS
         subjects affected / exposed
    0 / 56 (0.00%)
    4 / 55 (7.27%)
    0 / 180 (0.00%)
    5 / 175 (2.86%)
         occurrences all number
    0
    4
    0
    7
    LACRIMATION INCREASED
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 55 (1.82%)
    3 / 180 (1.67%)
    4 / 175 (2.29%)
         occurrences all number
    3
    1
    3
    5
    DRY EYE
         subjects affected / exposed
    5 / 56 (8.93%)
    7 / 55 (12.73%)
    22 / 180 (12.22%)
    25 / 175 (14.29%)
         occurrences all number
    7
    10
    25
    34
    CORNEAL TOUCH
         subjects affected / exposed
    0 / 56 (0.00%)
    3 / 55 (5.45%)
    0 / 180 (0.00%)
    1 / 175 (0.57%)
         occurrences all number
    0
    3
    0
    1
    CORNEAL ENDOTHELIAL CELL LOSS
         subjects affected / exposed
    4 / 56 (7.14%)
    6 / 55 (10.91%)
    6 / 180 (3.33%)
    11 / 175 (6.29%)
         occurrences all number
    4
    6
    6
    13
    CONJUNCTIVAL HYPERAEMIA
         subjects affected / exposed
    13 / 56 (23.21%)
    21 / 55 (38.18%)
    22 / 180 (12.22%)
    35 / 175 (20.00%)
         occurrences all number
    22
    47
    23
    48
    PHOTOPHOBIA
         subjects affected / exposed
    1 / 56 (1.79%)
    5 / 55 (9.09%)
    2 / 180 (1.11%)
    15 / 175 (8.57%)
         occurrences all number
    1
    8
    2
    23
    PUNCTATE KERATITIS
         subjects affected / exposed
    5 / 56 (8.93%)
    7 / 55 (12.73%)
    19 / 180 (10.56%)
    21 / 175 (12.00%)
         occurrences all number
    5
    9
    25
    27
    VISION BLURRED
         subjects affected / exposed
    3 / 56 (5.36%)
    4 / 55 (7.27%)
    4 / 180 (2.22%)
    6 / 175 (3.43%)
         occurrences all number
    3
    4
    4
    6
    VISUAL FIELD DEFECT
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 55 (3.64%)
    18 / 180 (10.00%)
    18 / 175 (10.29%)
         occurrences all number
    0
    2
    22
    20
    VITREOUS FLOATERS
         subjects affected / exposed
    1 / 56 (1.79%)
    3 / 55 (5.45%)
    1 / 180 (0.56%)
    2 / 175 (1.14%)
         occurrences all number
    1
    3
    1
    2
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    4 / 56 (7.14%)
    4 / 55 (7.27%)
    3 / 180 (1.67%)
    3 / 175 (1.71%)
         occurrences all number
    5
    5
    3
    3
    Musculoskeletal and connective tissue disorders
    OSTEOARTHRITIS
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    2 / 180 (1.11%)
    2 / 175 (1.14%)
         occurrences all number
    4
    4
    2
    2
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    1 / 180 (0.56%)
    1 / 175 (0.57%)
         occurrences all number
    3
    3
    1
    1
    CONJUNCTIVITIS
    Additional description: ocular event
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    5 / 180 (2.78%)
    9 / 175 (5.14%)
         occurrences all number
    0
    0
    5
    10
    COVID-19
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 55 (0.00%)
    14 / 180 (7.78%)
    14 / 175 (8.00%)
         occurrences all number
    0
    0
    15
    15
    NASOPHARYNGITIS
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    8 / 180 (4.44%)
    8 / 175 (4.57%)
         occurrences all number
    5
    5
    8
    8
    Metabolism and nutrition disorders
    HYPERGLYCAEMIA
         subjects affected / exposed
    3 / 56 (5.36%)
    3 / 55 (5.45%)
    0 / 180 (0.00%)
    0 / 175 (0.00%)
         occurrences all number
    3
    3
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2015
    This protocol was amended to clarify some sections, to modify the inclusion/exclusion criteria, and to remove the LUMIGAN challenge.
    01 May 2017
    This protocol was amended to change the screening requirement for angle eligibility confirmation, modify/clarify the inclusion/exclusion criteria, and change additional procedures for patients with sickle cell disease from required to optional.
    05 Sep 2018
    This protocol was amended to change the Bimatoprost SR dose strength under study from 15 μg to 10 μg, and to reduce the number of administration cycles from 3 to 2.
    31 Jan 2020
    This protocol was amended to extend the washout period and update the list of medications requiring washout, allow patients enrolled in the 192024-091/092 studies who were randomized to the control treatment and never received an implant to be considered for enrollment at the investigator’s discretion, and revise the statistical methods.
    21 Apr 2020
    This protocol was amended to add additional detail regarding Bimatoprost SR retreatment criteria.
    28 Aug 2020
    This protocol was amended to lengthen the study duration, to update retreatment criteria, and to add flexibility in the timing of Cycle 2 Bimatoprost SR administration for patients not meeting the retreatment criteria at Week 16.
    29 Sep 2021
    This protocol was amended to update the covariates in the primary analysis model, add a subgroup analyses for the flexible administration and clarify the differences in the analyses to be done for Bimatoprost SR 10 μg and Bimatoprost SR 15 μg.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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