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

NCT ID: NCT02371746

Last Updated: 2019-10-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2019-02-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Glaucoma and Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

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

Group Type EXPERIMENTAL

ENV515-3 Travoprost XR

Intervention Type DRUG

ENV515-1 Travoprost XR

Intervention Type DRUG

Cohort 2

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

Group Type EXPERIMENTAL

ENV515-3 Travoprost XR

Intervention Type DRUG

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)

Group Type EXPERIMENTAL

ENV515-3-2 Travoprost XR

Intervention Type DRUG

Interventions

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ENV515-3 Travoprost XR

Intervention Type DRUG

ENV515-1 Travoprost XR

Intervention Type DRUG

ENV515-3-2 Travoprost XR

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Envisia Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chandler, Arizona, United States

Site Status

Garden Grove, California, United States

Site Status

Inglewood, California, United States

Site Status

Redding, California, United States

Site Status

Morrow, Georgia, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Chesterfield, Missouri, United States

Site Status

Kansas City, Missouri, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Portland, Oregon, United States

Site Status

Sioux Falls, South Dakota, United States

Site Status

Austin, Texas, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ENV515-01

Identifier Type: -

Identifier Source: org_study_id

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