NCT02358369

Dose-Ranging Study of the Bimatoprost Ocular Insert

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: ForSight Vision5, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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%).

Conditions

• Primary Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Bimatoprost	Bimatoprost sustained release Ocular Insert
DRUG	Timolol 0.5%	BID drops OU, 0.5% ophthalmic solution
DEVICE	Placebo Ocular Insert	Placebo ocular insert OU.
DRUG	Placebo Eye Drops	Placebo eye drops BID OU.

Timeline

• Start date: 2015-01-19
• Primary completion: 2015-08-31
• Completion: 2015-10-07
• First posted: 2015-02-09
• Last updated: 2020-06-04
• Results posted: 2020-06-04

Locations

10 sites across 1 country: United States