CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 156 enrolled
Drug / intervention
Bimatoprost +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/NCT02358369
NCT02358369Phase 2Completed
CompareCT.gov

A Phase 2 Prospective, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety and Dose-response of the Bimatoprost Ocular Insert (2.2 mg, 13 mg) With and Without Concomitant Artificial Tears Compared to a Placebo Ocular Insert With and Without Concomitant Timolol (0.5%) Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension

ForSight Vision5, Inc.·interventional·Posted Feb 9, 2015·Updated Jun 4, 2020

In Brief

A Phase 2 clinical trial evaluating Bimatoprost, Timolol 0.5%, and 2 other interventions for Primary Open-Angle Glaucoma and Ocular Hypertension. Completed, enrolled 156 participants across 10 sites.

Detailed Summary

The Bimatoprost Ocular Insert is intended to provide sustained delivery of bimatoprost to the ocular surface to lower the intraocular pressure (IOP) in patients with Open-Angle Glaucoma or Ocular Hypertension. This study evaluated the safety and efficacy of two different doses of the Bimatoprost Ocular Insert, compared to an active control arm with timolol ophthalmic solution (0.5%).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Open-Angle Glaucoma, Ocular Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 9, 2015
Enrollment StartJan 19, 2015
Primary CompletionAug 31, 2015
Study CompletionOct 7, 2015
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.4 years ago

Interventions

Bimatoprostdrug

Bimatoprost sustained release Ocular Insert

Timolol 0.5%drug

BID drops OU, 0.5% ophthalmic solution

Placebo Ocular Insertdevice

Placebo ocular insert OU.

Placebo Eye Dropsdrug

Placebo eye drops BID OU.