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

Phase 2

Completed

• Conditions: Glaucoma and Ocular Hypertension
• Interventions: Drug: ENV515-3 Travoprost XR; Drug: ENV515-3-2 Travoprost XR; Drug: ENV515-1 Travoprost XR

• Registration Number: NCT02371746
• Lead Sponsor: Envisia Therapeutics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Primary Completion: 2019-02-13
• Study Completion: 2019-02-13
• Results First Submitted: 2019-07-15
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-26
• Last Update Submitted: 2019-09-26
• Results First Posted: 2019-10-17
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	ENV515-3 Travoprost XR	ENV515-1 and ENV515-3 implants in Study Eye for 28 days
Cohort 3	ENV515-3-2 Travoprost XR	One or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months)
Cohort 1	ENV515-1 Travoprost XR	ENV515-1 and ENV515-3 implants in Study Eye for 28 days
Cohort 2	ENV515-3 Travoprost XR	Two ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months)

Primary Outcome Measures

Name	Time	Method
Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)	Baseline and Day 25	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.