CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 528 enrolled
Drug / intervention
Bimatoprost SR +3 moredrug
Likely dose
Not stated in 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/NCT02250651
NCT02250651Phase 3Completed
CompareCT.gov

The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

Allergan·interventional·Posted Sep 26, 2014·Updated Jul 28, 2021

In Brief

A Phase 3 clinical trial evaluating Bimatoprost SR, Sham: Applicator Without Needle, and 2 other interventions for Glaucoma, Open-Angle and Ocular Hypertension. Completed, enrolled 528 participants across 113 sites in 15 countries.

Detailed Summary

This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Open-Angle, Ocular Hypertension
CountriesArgentina, Canada, Colombia, Czechia, Egypt, Germany, Italy, Malaysia, New Zealand, Singapore, South Africa, South Korea, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 26, 2014
Enrollment StartDec 15, 2014
Primary CompletionOct 25, 2018
Study CompletionJul 22, 2020
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 11.8 years ago

Interventions

Bimatoprost SRdrug

Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.

Sham: Applicator Without Needleother

Sham administered on Day 1, Week 16, and Week 32.

Active Comparator: Timolol 0.5%drug

Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Timolol Vehicle (placebo)drug

Timolol vehicle administered once in the morning and once in the evening for up to 20 months.