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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Travoprost
* Other: Placebo Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-TP (sustained release travoprost) Intracanalicular Depot<br>OTX-TP (sustained release travoprost) Intracanalicular Depot | Drug: Travoprost<br> <br> |
| Placebo Comparator: PV (Placebo Vehicle) Intracanalicular Depot<br>PV (Placebo Vehicle) Intracanalicular Depot | Other: Placebo Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP |  | Mean IOP at 8AM, 10AM, and 4PM at the 2 Week Visit | 
| Mean IOP |  | Mean IOP at 8AM, 10AM, and 4PM at the 6 Week Visit | 
| Mean IOP |  | Mean IOP at 8AM, 10AM, and 4PM at the 12 Week Visit |