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-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.

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: Inclusion Criteria: Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment. Exclusion Criteria: Exclusion Criteria: Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months. Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bimatoprost Sustained-Release (SR)<br>Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). | Drug: Bimatoprost SR<br>* Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).<br>Drug: Sham Bimatoprost SR<br>* Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).<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>|
| Active Comparator: Selective Laser Trabeculoplasty (SLT)<br>Assigned Primary Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). | Drug: Bimatoprost SR<br>* Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).<br>Drug: Sham Bimatoprost SR<br>* Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).<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 |
| --- | --- | --- |
| Change from Baseline in IOP at Week 4 |  | Baseline, Week 4 | 
| Change from Baseline in IOP at Week 12 |  | Baseline, Week 12 | 
| Change from Baseline in Intraocular Pressure (IOP) at Week 24 |  | Baseline, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change from baseline at Week 8 |  | Baseline, Week 8 | 
| IOP change from baseline at Week 15 |  | Baseline, Week 15 | 
| IOP change from baseline at Week 20 |  | Baseline, Week 20 | 
| Time to initial use of nonstudy IOP-lowering treatment as determined by the investigator |  | Baseline, Month 24 | 
| Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 4 |  | Baseline, Week 4 | 
| Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 12 |  | Baseline, Week 12 | 
| Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 24 |  | Baseline, Week 24 | 
| Percentage of SLT eyes achieving ≥ 20% reduction at Week 4 |  | Baseline, Week 4 | 
| Percentage of SLT eyes achieving ≥ 20% reduction at Week 12 |  | Baseline, Week 12 | 
| Percentage of SLT eyes achieving ≥ 20% reduction at Week 24 |  | Baseline, Week 24 |