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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02371746
Other study ID # ENV515-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 1, 2015
Est. completion date February 13, 2019

Study information

Verified date September 2019
Source Envisia Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date February 13, 2019
Est. primary completion date February 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.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


Intervention

Drug:
ENV515-3 Travoprost XR

ENV515-1 Travoprost XR

ENV515-3-2 Travoprost XR


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Envisia Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline and Day 25
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