Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT

• Status: Completed
• Trial end date: 2019-03-30
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocular Therapeutix, Inc.
• Treatments: Travoprost

Criteria

Inclusion Criteria:

• Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession

• IOP is currently controlled as assessed by the Investigator

Exclusion Criteria:

• Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge

• A history of an inadequate response or no response to topical prostaglandin

• Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products