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

Envisia Therapeutics

Status and phase: Completed; Phase 2

Conditions: Glaucoma and Ocular Hypertension

Treatments: Drug: ENV515-3-2 Travoprost XR; Drug: ENV515-3 Travoprost XR; Drug: ENV515-1 Travoprost XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT02371746

ENV515-01

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Cohort 1

Experimental group

Description:

ENV515-1 and ENV515-3 implants in Study Eye for 28 days

Treatment:

Drug: ENV515-3 Travoprost XR

Drug: ENV515-1 Travoprost XR

Cohort 2

Experimental group

Description:

Two ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months)

Treatment:

Drug: ENV515-3 Travoprost XR

Cohort 3

Experimental group

Description:

One or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months)

Treatment:

Drug: ENV515-3-2 Travoprost XR