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

Primary Purpose

Glaucoma and Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ENV515-3 Travoprost XR
ENV515-1 Travoprost XR
ENV515-3-2 Travoprost XR
Sponsored by
Envisia Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma and Ocular Hypertension

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 20, 2015
Last Updated
September 26, 2019
Sponsor
Envisia Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02371746
Brief Title
Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
February 13, 2019 (Actual)
Study Completion Date
February 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Envisia Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma and Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
ENV515-1 and ENV515-3 implants in Study Eye for 28 days
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Two ENV515-3 implants in Study Eye for 12 months with optional 6 month and 3 month extensions (total of 21 months)
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
One or two ENV515-3-2 implants in Study Eye with optional 6 months and additional 6 month extension (total of 24 months)
Intervention Type
Drug
Intervention Name(s)
ENV515-3 Travoprost XR
Intervention Type
Drug
Intervention Name(s)
ENV515-1 Travoprost XR
Intervention Type
Drug
Intervention Name(s)
ENV515-3-2 Travoprost XR
Primary Outcome Measure Information:
Title
Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1)
Description
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.
Time Frame
Baseline and Day 25

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
City
Redding
State/Province
California
ZIP/Postal Code
96002
Country
United States
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64133
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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