CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Fixed Combination +4 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/NCT02742649
NCT02742649Phase 2Completed

A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

ForSight Vision5, Inc.·interventional·Posted Apr 19, 2016·Updated Feb 25, 2019

In Brief

A Phase 2 clinical trial evaluating Fixed Combination, Bimatoprost, and 3 other interventions for Open-Angle Glaucoma and Ocular Hypertension. Completed, enrolled 55 participants across 1 site.

Detailed Summary

The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPanama
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 19, 2016
Enrollment StartApr 30, 2016
Primary CompletionDec 31, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.2 years ago

Interventions

Fixed Combinationdrug

Continuous elution from the ocular insert.

Bimatoprostdrug

Continuous elution from the ocular insert. This is an active control arm.

Timololdrug

Continuous elution from the ocular insert. This is an active control arm.

Placebo Segmentdevice

One segment of placebo (no drug product)

Timolol 0.5%drug

0.5% timolol drops twice daily.