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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Timolol | Other / unclassified | 0.5 % | Topical |
| Comparator | Travoprost | Other / unclassified | 0.36 mg | Other |