Overview

This trial is active, not recruiting.

Condition open-angle glaucoma
Treatments istent, travoprost
Phase phase 4
Sponsor Glaukos Corporation
Start date September 2011
End date January 2017
Trial size 100 participants
Trial identifier NCT01443988, GCF-022

Summary

Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.

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
Arm
(Active Comparator)
Implantation of two iStent devices
istent
Implantation of two iStent devices
(Active Comparator)
Travoprost drops
travoprost
Travoprost drops

Primary Outcomes

Measure
Change from screening in mean diurnal IOP (mm Hg) at the Month 12 visit.
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Phakic study eye - IOP ≥ 21 mmHg and ≤ 40 mmHg at screening exam (OHT requires second screening) Exclusion Criteria: - Aphakic or pseudophakic eyes (AC-IOLs or PC-IOLs) - Previous usage of topical prostaglandin analogues or prior medical therapy for glaucoma

Additional Information

Official title A Prospective, Randomized Evaluation of Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent) or Travoprost Ophthalmic Solution 0.004%
Principal investigator Lilit A Voskanyan, MD, PhD
Description Evaluation of the intraocular pressure (IOP) lowering effect of two iStent devices versus medical therapy in eyes of subjects with primary open-angle glaucoma, pseudoexfoliative glaucoma, or ocular hypertension naïve to medical and surgical therapy.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Glaukos Corporation.