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

Phase

Condition

Glaucoma

Vascular Diseases

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT02914509

OTX-16-002

Ages > 18
All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 orgreater or open-angle glaucoma without pseudoexfoliation or pigment dispersion orevidence of traumatic angle recession
IOP is currently controlled as assessed by the Investigator

Exclusion

Exclusion Criteria:

Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measuredusing 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

Study Design

November 07, 2016

March 30, 2019

Study Description

This was a prospective, multicenter, randomized, parallel-arm, double masked, placebo vehicle (PV) controlled study conducted to evaluate the safety and IOP-lowering efficacy of OTX-TP, a sustained release drug product placed in the canaliculus of the eyelid in subjects with open-angle glaucoma or ocular hypertension. A total of up to 550 subjects (1100 eyes) with a clinical diagnosis of open-angle glaucoma or ocular hypertension in both eyes received either OTX-TP or PV to evaluate the safety and efficacy of OTX-TP.

Connect with a study center

Artesia, California
United States
Site Not Available
Colorado Springs, Colorado
United States
Site Not Available
Lakeland, Florida
United States
Site Not Available
Morrow, Georgia
United States
Site Not Available
empty
Shawnee, Kansas
United States
Site Not Available
Shawnee Mission, Kansas
United States
Site Not Available
Des Peres, Missouri
United States
Site Not Available
Fichte, Endl & Elmer Eyecare
Amherst, New York 14228
United States
Site Not Available
Rochester, New York
United States
Site Not Available
Raleigh, North Carolina
United States
Site Not Available
Cincinnati, Ohio
United States
Site Not Available
Austin, Texas
United States
Site Not Available

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