NCT02636946

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Glaucoma
• Open-Angle Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Bimatoprost SR	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).
DRUG	Sham Bimatoprost SR	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).
PROCEDURE	Selective Laser Trabeculoplasty	Selective Laser Trabeculoplasty administered on Day 1.
PROCEDURE	Sham Selective Laser Trabeculoplasty	Sham Selective Laser Trabeculoplasty administered on Day 1.

Timeline

• Start date: 2016-02-24
• Primary completion: 2021-01-26
• Completion: 2021-01-26
• First posted: 2015-12-22
• Last updated: 2022-02-23
• Results posted: 2022-02-23

Locations

33 sites across 9 countries: United States, Australia, Denmark, France, Poland, Russia, Singapore, Spain, Thailand

Regulatory

• FDA-regulated drug study