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

Ocular Therapeutix, Inc.565 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

565

Conditions

Open Angle Glaucoma Ocular Hypertension

Interventions

TravoprostDRUG

Placebo VehicleOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Artesia, California, United States

Unnamed facility

Colorado Springs, Colorado, United States

Unnamed facility

Lakeland, Florida, United States

Unnamed facility

Morrow, Georgia, United States

Outcomes

Primary Outcomes

Mean IOP

Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit

Mean IOP

Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit

Mean IOP

Time frame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit

Data from ClinicalTrials.gov

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