This trial is active, not recruiting.

Condition primary open angle glaucoma (poag)
Treatments istent
Phase phase 4
Sponsor Glaukos Corporation
Start date January 2012
End date September 2017
Trial size 251 participants
Trial identifier NCT01517477, GCF-033


The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications.

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
Implantation of One iStent through a small temporal clear corneal incision.
Device: Two iStent devices
Implantation of Two iStents through a small temporal clear corneal incision
Device: Three iStent devices
Implantation of Three iStents through a small temporal clear corneal incision

Primary Outcomes

Mean diurnal intraocular pressure (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 March 2016.
Information provided to ClinicalTrials.gov by Glaukos Corporation.