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
Overview
- Phase
- Phase 3
- Intervention
- Placebo Vehicle
- Conditions
- Open Angle Glaucoma
- Sponsor
- Ocular Therapeutix, Inc.
- Enrollment
- 565
- Primary Endpoint
- Mean IOP
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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
Detailed 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.
Investigators
Eligibility 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
Arms & Interventions
PV (Placebo Vehicle) Intracanalicular Depot
PV (Placebo Vehicle) Intracanalicular Depot
Intervention: Placebo Vehicle
OTX-TP (sustained release travoprost) Intracanalicular Depot
OTX-TP (sustained release travoprost) Intracanalicular Depot
Intervention: Travoprost
Outcomes
Primary Outcomes
Mean IOP
Time Frame: Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit