Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.

Official Title
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A Prospective, Multicenter, Randomized, Double-Masked, Multi-Arm Feasibility 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

Intervention / Treatment
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* Drug: OTX-TPa  4µg/day over 2 mos. with natural tears drops
* Drug: OTX-TPb  3µg/day over 3 months with natural tears drops
* Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be greater than or equal to 18 years of age at Screening. Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma. Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits. Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart. Exclusion Criteria: Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis). Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm. Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of >34 mm Hg.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-TPa<br>OTX-TPa is a hydrogel punctum plug eluting travoprost in sustained release of  4µg/day over approximately 2 months. For study masking purposes, subjects in this arm will also have natural tears drops administered. | Drug: OTX-TPa  4µg/day over 2 mos. with natural tears drops<br>* OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of  4µg/day over 2 months. Subjects in this arm will also receive natural tears drops.<br>|
| Experimental: OTX-TPb<br>OTX-TPb is a hydrogel punctum plug eluting travoprost in sustained release of  3µg/day over approximately 3 months. For study masking purposes, subjects in this arm will also have natural tears drops administered. | Drug: OTX-TPb  3µg/day over 3 months with natural tears drops<br>* OTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of  3µg/day over 3 months. Subjects in this arm will also receive natural tears drops.<br>|
| Active Comparator: Timolol<br>Timolol Maleate (0.5%) ophthalmic solution dosed twice daily (BID). For study masking purposes, subjects in this arm will also have a hydrogel punctum plug with no drug placed for approximately 3 months. | Drug: Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug<br>* Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean IOP change from baseline |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization of OTX-TP punctum plug by subject | OTX-TP punctum plug contains conjugated fluorescein to serve as a visualization aid through use of a blue light source and yellow filter to confirm product presence daily by subject for 90 days. | 90 days |