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

September 26, 2019 updated by: Envisia Therapeutics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
    • California
      • Garden Grove, California, United States, 92843
      • Inglewood, California, United States, 90301
      • Redding, California, United States, 96002
    • Georgia
      • Morrow, Georgia, United States, 30260
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Missouri
      • Chesterfield, Missouri, United States, 63017
      • Kansas City, Missouri, United States, 64133
    • Ohio
      • Cincinnati, Ohio, United States, 45242
    • Oregon
      • Portland, Oregon, United States, 97210
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
    • Texas
      • Austin, Texas, United States, 78731
      • Houston, Texas, United States, 77025
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
ENV515-1 and ENV515-3 implants in Study Eye for 28 days
Drug: ENV515-3 Travoprost XR
Drug: ENV515-1 Travoprost XR
Experimental: Cohort 2
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
Experimental: Cohort 3
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

What is the study measuring?

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)
Time Frame: 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.
Baseline and Day 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Envisia Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

February 13, 2019

Study Completion (Actual)

February 13, 2019

Study Registration Dates

First Submitted

February 20, 2015

First Submitted That Met QC Criteria

February 20, 2015

First Posted (Estimate)

February 26, 2015

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENV515-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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