OTX-16-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-TP in Subjects With Open-Angle Glaucoma and Ocular Hypertension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:9/15/2017
Start Date:September 2016
Contact:Deepa Mulani
Email:dmulani@ocutx.com
Phone:781-357-4000

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A Prospective, Multicenter, Randomized, Parallel-Arm, Double Masked, Vehicle Controlled Phase 3A Study Evaluating the Safety and Efficacy of OTX-TP in the Treatment of Subjects With Open-Angle Glaucoma or Ocular Hypertension

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


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
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