NCT02742649

A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

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)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: ForSight Vision5, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Fixed Combination	Continuous elution from the ocular insert.
DRUG	Bimatoprost	Continuous elution from the ocular insert. This is an active control arm.
DRUG	Timolol	Continuous elution from the ocular insert. This is an active control arm.
DEVICE	Placebo Segment	One segment of placebo (no drug product)
DRUG	Timolol 0.5%	0.5% timolol drops twice daily.

Timeline

• Start date: 2016-04-30
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2016-04-19
• Last updated: 2019-02-25
• Results posted: 2018-12-31

Locations

1 site across 1 country: Panama