drugset / Trial / NCT02358369

Dose-Ranging Study of the Bimatoprost Ocular Insert

NCT02358369

Phase 2 Completed 156 enrolled ForSight Vision5, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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%).

Timeline

Start
2015-01-19
Primary completion
2015-08-31
Completion
2015-10-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bimatoprost Other / unclassified 2.2 mg Topical
Subject Bimatoprost Other / unclassified 13 mg Topical
Comparator Timolol Other / unclassified 0.5 % Topical