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 |
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
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
We found this trial at
10
sites
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