A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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This 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).

Official Title
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A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Glaucoma, Open-Angle Ocular Hypertension

Intervention / Treatment
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* Drug: Bimatoprost SR
* Drug: Sham Bimatoprost SR
* Procedure: Selective Laser Trabeculoplasty
* Procedure: Sham Selective Laser Trabeculoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment. Exclusion Criteria: Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months. Enrollment in other studies using Bimatoprost SR.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)<br>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. | Drug: Bimatoprost SR<br>* 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).<br>Drug: Sham Bimatoprost SR<br>* Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).<br>Procedure: Selective Laser Trabeculoplasty<br>* Selective Laser Trabeculoplasty administered on Day 1.<br>Procedure: Sham Selective Laser Trabeculoplasty<br>* Sham Selective Laser Trabeculoplasty administered on Day 1.<br>|
| Experimental: Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)<br>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. | Drug: Bimatoprost SR<br>* 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).<br>Drug: Sham Bimatoprost SR<br>* Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).<br>Procedure: Selective Laser Trabeculoplasty<br>* Selective Laser Trabeculoplasty administered on Day 1.<br>Procedure: Sham Selective Laser Trabeculoplasty<br>* Sham Selective Laser Trabeculoplasty administered on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) at Baseline | IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. | Baseline (prior to treatment) | 
| Change From Baseline in IOP at Week 4 | 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. | Baseline (prior to treatment) to Week 4 | 
| Change From Baseline in IOP at Week 12 | 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. | Baseline (prior to treatment) to Week 12 | 
| Change From Baseline in Intraocular Pressure (IOP) at Week 24 | 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. | Baseline (prior to treatment) to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in IOP at Weeks 8, 15, and 20 | 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. | Baseline (prior to treatment) to Weeks 8, 15 and 20 | 
| Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator | Median time in days from first treatment to the initial use of non-study IOP-lowering treatment. | First treatment to end of study (up to 525 days) | 
| Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP | 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. | 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 |