A Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant for Patients With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Study Overview
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Brief Summary
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To assess efficacy, and safety of a single sustained release dose of the OTX-TIC drug product (2 travoprost dose strengths) in subjects with Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Detailed Description
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This is a prospective, multi-center, randomized, parallel-group, controlled study to evaluate the efficacy, and safety of OTX-TIC (travoprost) intracameral implant in subjects with open angle glaucoma (OAG) or ocular hypertension (OHT). Approximately 105 subjects will be enrolled in this study at approximately 20 sites in the US. Subjects will be a randomized to one of three treatment groups OTX-TIC drug product (2 travoprost dose strengths) compared to a single injection of DurystaTM. Non study eyes will be treated with the PGA, if not contraindicated.

Official Title
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A Prospective, Multi-center, Randomized, Parallel-group, Controlled Study to Evaluate the Efficacy and Safety of OTX-TIC (Travoprost) Intracameral Implant in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: OTX-TIC low dose Travoprost Intracameral Implant
* Drug: OTX-TIC high dose Travoprost Intracameral Implant
* Drug: Durysta, Bimatoprost Intracameral Implant 10 µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are 18 years of age or older at the time of screening Provide written informed consent and are able to comply with all study requirements Are willing to withhold glaucoma medications according to the study requirements, and in the opinion of the investigator can do so without significant risk Have a negative pregnancy test result for women of childbearing potential at Baseline Have a documented diagnosis of OHT, or OAG in the study eye Exclusion Criteria: Have an uncontrolled systemic disease or a debilitating disease (e.g., cardiovascular, hypertension, uncontrolled diabetes) Are currently pregnant or breast-feeding or of childbearing potential without the use of adequate contraceptive methods during the length of the study Non-responsive to topical prostaglandins, prostamides or prostaglandin analogs

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
Interventional Model Description: Parallel: Participants are assigned to one of three groups in parallel for the duration of the study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-TIC Low Dose<br>Travoprost Intracameral Implant low dose | Drug: OTX-TIC low dose Travoprost Intracameral Implant<br>* OTX-TIC implant is injected into the anterior chamber of the eye.<br>|
| Experimental: OTX-TIC High Dose<br>Travoprost Intracameral Implant high dose | Drug: OTX-TIC high dose Travoprost Intracameral Implant<br>* OTX-TIC implant is injected into the anterior chamber of the eye.<br>|
| Active Comparator: Durysta<br>Bimatoprost Intracameral Implant 10 µg | Drug: Durysta, Bimatoprost Intracameral Implant 10 µg<br>* Durysta is injected into the anterior chamber of the eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Outcome: IOP changes from Baseline | IOP changes from baseline at 8AM, 10AM, and 4PM at Week 2, Week 6, and Week 12 in the study eye | Diurnal IOP [Time Frame: diurnal IOP at the 2 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 6 Week Visit] Diurnal IOP [Time Frame: diurnal IOP at the 12 Week Visit] |