NCT01915940

Bimatoprost Ocular Insert Compared to Topical Timolol Solution in Patients With Glaucoma or Ocular Hypertension

A Phase 2, Multicenter, Randomized, Subject- and Examiner-masked, Controlled Clinical Trial Designed to Evaluate the Safety and Effectiveness of the Bimatoprost Ocular Insert as Compared to Topical Timolol Solution (0.5%) in Patients With Glaucoma or Ocular Hypertension.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: ForSight Vision5, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this Phase 2 study is to evaluate whether the Bimatoprost Ocular Insert is non-inferior to that of timolol ophthalmic solution (0.5%) at 12 weeks.

Conditions

• Primary Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Bimatoprost	Bimatoprost ocular insert
DRUG	Timolol 0.5%	Timolol 0.5% solution
DRUG	Placebo Eye Drops	Placebo topical eye drops
DEVICE	Placebo Ocular Insert	Ocular insert without any active drug

Timeline

• Start date: 2013-10-23
• Primary completion: 2014-09-30
• Completion: 2014-11-14
• First posted: 2013-08-05
• Last updated: 2018-04-20
• Results posted: 2018-04-20

Locations

10 sites across 1 country: United States