Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma

Study Overview
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Brief Summary
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This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.

Official Title
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A Multi-Center, Three-Stage, Open-Label, Prospective, Active-Comparator-Controlled Phase 2a Study of ENV515 (Travoprost) Intracameral Implant in Patients With Bilateral Ocular Hypertension or Early Primary Open-Angle Glaucoma

Conditions
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Glaucoma and Ocular Hypertension

Intervention / Treatment
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* Drug: ENV515-3 Travoprost XR
* Drug: ENV515-1 Travoprost XR
* Drug: ENV515-3-2 Travoprost XR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of either ocular hypertension or open angle glaucoma in both eyes. Are currently treated with topical PGA for ocular hypertension in both eyes. Patients who in the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial. Exclusion Criteria: Eye surgery (including cataract surgery) within the past 3 months. History of glaucoma related surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>ENV515-1 and ENV515-3 implants in Study Eye for 28 days | Drug: ENV515-3 Travoprost XR<br> <br> Drug: ENV515-1 Travoprost XR<br> <br> |
| Experimental: Cohort 2<br>Two ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months) | Drug: ENV515-3 Travoprost XR<br> <br> |
| Experimental: Cohort 3<br>One or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months) | Drug: ENV515-3-2 Travoprost XR<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1) | Average intraocular pressure (IOP) diurnal measurement is calculated by taking the average of the intraocular pressure measurements at 8AM, 10AM and 4PM. The protocol was later amended (Amendment 09) to a safety only study so the diurnal measurements were no longer collected for Cohorts 2 and 3; only the 8AM IOP was collected as a safety assessment only. | Baseline and Day 25 |