This trial is active, not recruiting.

Condition primary open angle glaucoma (poag)
Treatments istent
Phase phase 4
Sponsor Glaukos Corporation
Start date December 2010
End date July 2016
Trial size 120 participants
Trial identifier NCT01252849, GCF-016


The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Device: One iStent, medication
Implantation of One iStent through a small temporal clear corneal incision.
Device: Two iStent devices, medication
Implantation of Two iStents through a small temporal clear corneal incision
Device: Three iStent devices, medication
Implantation of Three iStents through a small temperal clear corneal incision

Primary Outcomes

Mean diurnal IOP reduction of greater than or equal to 20% at month 12 vs. baseline
time frame: 12 Months

Secondary Outcomes

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) - Subject on two topical hypotensive medications Exclusion Criteria: - Traumatic, uveitic, neovascular, or angle closure glaucoma - Fellow eye already enrolled

Additional Information

Official title A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Glaukos Corporation.