Clinical Trial Results:
A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients with Open-Angle Glaucoma or Ocular Hypertension
Summary
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EudraCT number |
2015-003631-34 |
Trial protocol |
BE ES CZ FR DK IT |
Global end of trial date |
26 Jan 2021
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Results information
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Results version number |
v2(current) |
This version publication date |
23 Mar 2022
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First version publication date |
10 Feb 2022
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
192024-095
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02636946 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Allergan Limited
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Sponsor organisation address |
Marlow International The Parkway, Marlow Buckinghamshire, United Kingdom, SL7 1YL
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Public contact |
Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.com
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Scientific contact |
Global Medical Services, AbbVie, AbbVie Deutschland GmbH & Co. KG, 001 8006339110, abbvieclinicaltrials@abbvie.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
26 Jan 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
26 Jan 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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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).
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Protection of trial subjects |
All study participants were required to read and sign an Informed Consent Form.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
24 Feb 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Singapore: 3
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Country: Number of subjects enrolled |
Thailand: 2
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Country: Number of subjects enrolled |
Denmark: 5
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Country: Number of subjects enrolled |
Poland: 8
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Country: Number of subjects enrolled |
Russian Federation: 6
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Country: Number of subjects enrolled |
Spain: 2
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Country: Number of subjects enrolled |
United States: 115
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Country: Number of subjects enrolled |
France: 3
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Worldwide total number of subjects |
144
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EEA total number of subjects |
18
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
91
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From 65 to 84 years |
53
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||
Pre-assignment
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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
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Period 1 title |
Cycle 1 (Day 1 to Week 15)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind [1] | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Carer, Assessor | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
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Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Implant in pre-filled syringe
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Routes of administration |
Ophthalmic use
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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).
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Investigational medicinal product name |
Sham Bimatoprost SR: Applicator Without Needle
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Solution for injection in needle-free injector
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Routes of administration |
Ophthalmic use
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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).
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Investigational medicinal product name |
Selective Laser Trabeculoplasty
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Selective Laser Trabeculoplasty administered on Day 1.
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Investigational medicinal product name |
Sham Selective Laser Trabeculoplasty
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Sham Selective Laser Trabeculoplasty administered on Day 1.
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Arm title
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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
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Implant in pre-filled syringe
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Routes of administration |
Ophthalmic use
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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).
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Investigational medicinal product name |
Sham Bimatoprost SR: Applicator Without Needle
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Solution for injection in needle-free injector
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Routes of administration |
Ophthalmic use
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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).
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Investigational medicinal product name |
Selective Laser Trabeculoplasty
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Investigational medicinal product code |
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Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Selective Laser Trabeculoplasty administered on Day 1.
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Investigational medicinal product name |
Sham Selective Laser Trabeculoplasty
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Sham Selective Laser Trabeculoplasty administered on Day 1.
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Notes [1] - The roles blinded appear to be inconsistent with a double blind trial. Justification: The investigator was not blinded. |
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Period 2
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Period 2 title |
Cycle 2 (Week 16 to Week 31)
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind [2] | ||||||||||||||||||||||||||||||
Roles blinded |
Carer, Assessor, Subject | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Implant in pre-filled syringe
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Routes of administration |
Ophthalmic use
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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).
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Investigational medicinal product name |
Sham Bimatoprost SR: Applicator Without Needle
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Solution for injection in needle-free injector
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Routes of administration |
Ophthalmic use
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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).
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Investigational medicinal product name |
Selective Laser Trabeculoplasty
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Selective Laser Trabeculoplasty administered on Day 1.
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Investigational medicinal product name |
Sham Selective Laser Trabeculoplasty
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Sham Selective Laser Trabeculoplasty administered on Day 1.
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Arm title
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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
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Implant in pre-filled syringe
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Routes of administration |
Ophthalmic use
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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).
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Investigational medicinal product name |
Sham Bimatoprost SR: Applicator Without Needle
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Solution for injection in needle-free injector
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||||||||||||||||||||||||||||||
Routes of administration |
Ophthalmic use
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||||||||||||||||||||||||||||||
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).
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Investigational medicinal product name |
Selective Laser Trabeculoplasty
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Pharmaceutical dose form not applicable
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||||||||||||||||||||||||||||||
Routes of administration |
Ophthalmic use
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||||||||||||||||||||||||||||||
Dosage and administration details |
Selective Laser Trabeculoplasty administered on Day 1.
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||||||||||||||||||||||||||||||
Investigational medicinal product name |
Sham Selective Laser Trabeculoplasty
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Investigational medicinal product code |
|||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||
Pharmaceutical forms |
Pharmaceutical dose form not applicable
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Sham Selective Laser Trabeculoplasty administered on Day 1.
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Notes [2] - The roles blinded appear to be inconsistent with a double blind trial. Justification: The investigator was not blinded. |
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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 |
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Period 3
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Period 3 title |
Cycle 3 (Week 32 to Week 52)
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Is this the baseline period? |
No | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||
Blinding used |
Double blind [4] | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Carer, Assessor | ||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
|
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
|
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Routes of administration |
Ophthalmic use
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Dosage and administration details |
Sham Selective Laser Trabeculoplasty administered on Day 1.
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Implant in pre-filled syringe
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Routes of administration |
Ophthalmic use
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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).
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Investigational medicinal product name |
Sham Bimatoprost SR: Applicator Without Needle
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in needle-free injector
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Routes of administration |
Ophthalmic use
|
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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).
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Investigational medicinal product name |
Selective Laser Trabeculoplasty
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
|
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Routes of administration |
Ophthalmic use
|
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Dosage and administration details |
Selective Laser Trabeculoplasty administered on Day 1.
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Investigational medicinal product name |
Sham Selective Laser Trabeculoplasty
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pharmaceutical dose form not applicable
|
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Routes of administration |
Ophthalmic use
|
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Dosage and administration details |
Sham Selective Laser Trabeculoplasty administered on Day 1.
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Notes [4] - The roles blinded appear to be inconsistent with a double blind trial. Justification: The investigator was not blinded. |
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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 |
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Baseline characteristics reporting groups
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Reporting group title |
SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)
|
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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)
|
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
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End points reporting groups
|
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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.
|
|
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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.
|
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End point type |
Primary
|
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End point timeframe |
Baseline (prior to treatment) to Week 4
|
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|
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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).
|
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Comparison groups |
Selective Laser Trabeculoplasty v Bim SR 15 μg
|
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Number of subjects included in analysis |
266
|
||||||||||||
Analysis specification |
Pre-specified
|
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Analysis type |
non-inferiority [1] | ||||||||||||
P-value |
= 0.0166 | ||||||||||||
Method |
MMRM | ||||||||||||
Parameter type |
Least-squares Mean Difference | ||||||||||||
Point estimate |
-0.7
|
||||||||||||
Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
|
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lower limit |
-1.28 | ||||||||||||
upper limit |
-0.13 | ||||||||||||
Variability estimate |
Standard error of the mean
|
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Dispersion value |
0.29
|
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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. |
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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.
|
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End point type |
Primary
|
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End point timeframe |
Baseline (prior to treatment) to Week 12
|
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|
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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).
|
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Comparison groups |
Selective Laser Trabeculoplasty v Bim SR 15 μg
|
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Number of subjects included in analysis |
250
|
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Analysis specification |
Pre-specified
|
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Analysis type |
non-inferiority [2] | ||||||||||||
P-value |
= 0.0735 | ||||||||||||
Method |
MMRM | ||||||||||||
Parameter type |
Least-squares Mean Difference | ||||||||||||
Point estimate |
-0.52
|
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Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
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lower limit |
-1.09 | ||||||||||||
upper limit |
0.05 | ||||||||||||
Variability estimate |
Standard error of the mean
|
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Dispersion value |
0.29
|
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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. |
|
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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.
|
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End point type |
Primary
|
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End point timeframe |
Baseline (prior to treatment) to Week 24
|
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|
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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).
|
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Comparison groups |
Selective Laser Trabeculoplasty v Bim SR 15 μg
|
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Number of subjects included in analysis |
243
|
||||||||||||
Analysis specification |
Pre-specified
|
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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
|
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lower limit |
-0.81 | ||||||||||||
upper limit |
0.32 | ||||||||||||
Variability estimate |
Standard error of the mean
|
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Dispersion value |
0.29
|
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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. |
|
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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.
|
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End point type |
Secondary
|
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End point timeframe |
Baseline (prior to treatment) to Weeks 8, 15 and 20
|
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|
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No statistical analyses for this end point |
|
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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.
|
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End point type |
Secondary
|
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End point timeframe |
First treatment to end of study (up to 525 days)
|
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|
|||||||||||||
No statistical analyses for this end point |
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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.
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End point type |
Secondary
|
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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
|
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|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
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Adverse events information
|
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Timeframe for reporting adverse events |
First treatment to end of study (up to 525 days)
|
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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.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.1
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Reporting groups
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Reporting group title |
Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)
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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)
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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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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. |
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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. |
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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. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |