NCT02312544

Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

A Prospective, Multicenter, Randomized, Double-Masked, Parallel-Arm Phase 2b Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic Solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension. The study is designed to assess clinically meaningful response to treatment and is not powered to measure any efficacy endpoints with statistical significance.

Conditions

• Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	OTX-TP	OTX-TP and placebo drops
DRUG	Timolol	Timolol drops and placebo punctum plug

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2014-12-09
• Last updated: 2016-12-14

Locations

1 site across 1 country: United States