Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension

AbbVie

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Glaucoma, Open-Angle

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02507687

2015-002131-18 (EudraCT Number)

192024-093

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 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).

Enrollment: 240 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.
• In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
• In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.

Exclusion criteria

• History of previous laser trabeculoplasty
• History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
• Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
• Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 4 patient groups

Stage 1: SLT (Primary Eye) / Bimatoprost SR 15 µg (Contralateral Eye)

Experimental group

Description:

Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Selective laser trabeculoplasty (SLT) administered on Day 1 followed by up to three sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).

Treatment:

Procedure: Selective Laser Trabeculoplasty

Procedure: Sham Selective Laser Trabeculoplasty

Drug: Sham Bimatoprost SR

Drug: Bimatoprost SR

Stage 1: Bimatoprost SR 15 µg (Primary Eye) / SLT (Contralateral Eye)

Experimental group

Description:

Participants enrolled prior to implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to three bimatoprost SR 15 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to three sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2) and Week 32 (Cycle 3; participants who reach Week 32 prior to implementation of Protocol Amendment 3 only).

Treatment:

Procedure: Selective Laser Trabeculoplasty

Procedure: Sham Selective Laser Trabeculoplasty

Drug: Sham Bimatoprost SR

Drug: Bimatoprost SR

Stage 2: SLT (Primary Eye) / Bimatoprost SR 10 µg (Contralateral Eye)

Experimental group

Description:

Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Contralateral Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria are met.

Treatment:

Procedure: Selective Laser Trabeculoplasty

Procedure: Sham Selective Laser Trabeculoplasty

Drug: Sham Bimatoprost SR

Drug: Bimatoprost SR

Stage 2: Bimatoprost SR 10 µg (Primary Eye) / SLT (Contralateral Eye)

Experimental group

Description:

Participants enrolled after implementation of Protocol Amendment 3 receive the following treatment in each eye: Assigned Primary Eye: Sham SLT administered on Day 1 followed by up to two bimatoprost SR 10 µg administrations. Contralateral Eye: SLT administered on Day 1 followed by up to two sham bimatoprost SR administrations. Bimatoprost SR/sham bimatoprost SR is administered on Day 4 (Cycle 1) and at Week 16 (Cycle 2). After implementation of Protocol Amendment 6, Cycle 2 retreatment could occur after Week 16 and prior to Month 12 based on when retreatment criteria were met.

Treatment:

Procedure: Selective Laser Trabeculoplasty

Procedure: Sham Selective Laser Trabeculoplasty

Drug: Sham Bimatoprost SR

Drug: Bimatoprost SR