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

Glaucoma and Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371746
• Other study ID #: ENV515-01
• Status: Completed
• Phase: Phase 2
• 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
• 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the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma and Ocular Hypertension
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension

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