Overview

This trial is active, not recruiting.

Condition subjects with primary open-angle glaucoma (poag)
Treatment istents
Phase phase 4
Sponsor Glaukos Corporation
Start date December 2010
End date July 2016
Trial size 40 participants
Trial identifier NCT01252888, GCF-018

Summary

The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Implantation of two iStents through small temporal clear corneal incision
istents
Implantation of two iStents through a small temporal clear corneal incision

Primary Outcomes

Measure
mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline
time frame: 12 months

Secondary Outcomes

Measure
Mean diurnal IOP < 18 mmHg at month 12
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with primary open-angle glaucoma (POAG) - Subjects on two topical hypotensive medications Exclusion Criteria: - Traumatic, uveitic, neovascular, or angle closure glaucoma - Fellow eye already enrolled

Additional Information

Official title A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
Description This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Glaukos Corporation.