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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - 85
Updated:3/13/2019
Start Date:January 1, 2015
End Date:February 13, 2019

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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

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.


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considered to be adequately controlled, can be safely withdrawn from IOP medications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.
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