At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 81 enrolled

Drug / intervention

Bimatoprostdrug

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/NCT02537015

NCT02537015Phase 2Completed

Compare CT.gov

An Open-label Extension (OLE 2) Study to Evaluate the Safety of the 13 mg Bimatoprost Ocular Insert in Subjects With Open-angle Glaucoma or Ocular Hypertension Who Have Completed Study FSV5-004

ForSight Vision5, Inc.·interventional·Posted Sep 1, 2015·Updated Apr 2, 2019

In Brief

A Phase 2 clinical trial evaluating Bimatoprost for Primary Open-Angle Glaucoma and Ocular Hypertension. Completed, enrolled 81 participants across 9 sites.

Detailed Summary

This study evaluated the long-term (9-months) safety of the Bimatoprost Ocular Insert in participants with Glaucoma or Ocular Hypertension who completed study FSV5-004. All the participants received Bimatoprost Ocular Insert and wore it for approximately 3 months (12 weeks), then had that Insert removed and a new Insert placed for another 26 weeks (approximately 6 months).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPrimary Open-Angle Glaucoma, Ocular Hypertension

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartAug 2015

First PostedSep 2015

Primary CompletionAug 2016

TodayJul 2026

First PostedSep 1, 2015

Enrollment StartAug 10, 2015

Primary CompletionAug 11, 2016

TodayJul 2, 2026

Enrollment to primary: 1.0 yearsPosted 10.8 years ago

Interventions

Bimatoprostdrug

Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.