drugset / Trial / 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

NCT02312544

Phase 2 Completed 72 enrolled Ocular Therapeutix, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-11
Primary completion
2015-09
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Timolol Other / unclassified 0.5 % Topical
Comparator Travoprost Other / unclassified 0.36 mg Other