Phase 2b Study Evaluating Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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To evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid compared to Timolol Maleate Ophthalmic Solution, 0.5% in the treatment of subjects with open angle glaucoma or ocular hypertension. The study is designed to assess clinically meaningful response to treatment and is not powered to measure any efficacy endpoints with statistical significance.

Official Title
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A Prospective, Multicenter, Randomized, Double-Masked, Parallel-Arm Phase 2b Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension

Conditions
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Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: OTX-TP
* Drug: Timolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma (with or without pseudoexfoliation or pigment dispersion component). Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of ≥ 24mmHg at Hour 0 (T0) at Baseline Visit 1 and Baseline Visit 2 (Day 1) Subject has a mean baseline IOP following washout in at least 1 eye (the same eye) of: ≥ 22mmHg at (T0 + 4h) and (T0 + 8h) at Baseline Visit 1 (note: the same eye must meet the IOP eligibility criteria at all 4 baseline assessments) Washout IOP must be ≤ 34mmHg in each eye at all time points at the Baseline Visit 1 and Baseline Visit 2 (Day 1) Exclusion Criteria: Subject with any form of glaucoma other than open angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component). Subject with mean baseline IOP >34 mmHg in either eye at any time point during the Baseline Visits 1 or 2 (Day 1). Subject with a BCVA worse than 0.6 logMAR (20/80 Snellen) in either eye as measured using an ETDRS chart. Subject with a known or suspected allergy and/or hypersensitivity to travoprost, timolol, 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 |
| --- | --- |
| Active Comparator: OTX-TP treatment<br>OTX-TP (sustained release travoprost, 0.36 mg) to be used in this trial with placebo drops administered separately | Drug: OTX-TP<br>* OTX-TP and placebo drops<br>|
| Active Comparator: Timolol control<br>Timolol Maleate Ophthalmic Solution, 0.5% dosed twice daily (BID) in the presence of a placebo vehicle punctum plug (PV). | Drug: Timolol<br>* Timolol drops and placebo punctum plug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 60 Visit |  | Days 57 to 63 | 
| Difference in the mean change from baseline average diurnal IOP between treatment groups at the Day 90 Visit |  | Days 87 to 93 | 
| Difference in the mean change from baseline IOP between treatment groups to each individual time point at the Day 60 and 90 Visits |  | Days 57 to 63 and Days 87 to 93 | 
| Difference in mean IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits |  | Days 57 to 63 and Days 87 to 93 | 
| Difference in the mean percent change from baseline IOP between treatment groups for the average diurnal IOP and to each individual time point at the Day 60 and 90 Visits |  | Days 57 to 63 and 87 to 93 |