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

Allergan

Status and phase: Completed; Phase 3

Conditions: Open-Angle Ocular Hypertension; Glaucoma

Treatments: Procedure: Selective Laser Trabeculoplasty; Procedure: Sham Selective Laser Trabeculoplasty; Drug: Sham Bimatoprost SR; Drug: Bimatoprost SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT02636946

192024-095

2015-003631-34 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups

SLT (Primary Eye) / Bim SR 15 µg (Contralateral Eye)

Active Comparator 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.

Treatment:

Drug: Sham Bimatoprost SR

Drug: Bimatoprost SR

Procedure: Selective Laser Trabeculoplasty

Procedure: Sham Selective Laser Trabeculoplasty

Bim SR 15 µg (Primary Eye) / SLT (Contralateral Eye)

Experimental 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.

Treatment:

Drug: Sham Bimatoprost SR

Drug: Bimatoprost SR

Procedure: Selective Laser Trabeculoplasty

Procedure: Sham Selective Laser Trabeculoplasty