CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 144 enrolled
Drug / intervention
Bimatoprost SR +3 moredrug
Likely dose
Bimatoprost SR 15 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02636946
NCT02636946Phase 3Completed

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

Allergan·interventional·Posted Dec 22, 2015·Updated Feb 23, 2022

In Brief

A Phase 3 clinical trial evaluating Bimatoprost SR, Sham Bimatoprost SR, and 2 other interventions for Glaucoma and Open-Angle Ocular Hypertension. Completed, enrolled 144 participants across 33 sites in 9 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Denmark, France, Poland, Russia, Singapore, Spain, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartFeb 24, 2016
Primary CompletionJan 26, 2021
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 10.5 years ago

Interventions

Bimatoprost SRdrug

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).

Sham Bimatoprost SRdrug

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).

Selective Laser Trabeculoplastyprocedure

Selective Laser Trabeculoplasty administered on Day 1.

Sham Selective Laser Trabeculoplastyprocedure

Sham Selective Laser Trabeculoplasty administered on Day 1.