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


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
Implantation of two iStents through small temporal clear corneal incision
Implantation of two iStents through a small temporal 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) - 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.