A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

Glaukos Corporation16 sites in 9 countries192 target enrollmentMay 2009

ConditionsEye Diseases Glaucoma, Open-Angle Glaucoma

InterventionsiStent latanoprost/timolol

Drugslatanoprost/timolol

Overview

Phase: Phase 4
Intervention: iStent
Conditions: Eye Diseases
Sponsor: Glaukos Corporation
Enrollment: 192
Locations: 16
Primary Endpoint: Mean intraocular pressure (IOP)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

Detailed Description

Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

September 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Glaukos Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of primary open-angle glaucoma
•Male or female at least 18 years of age and able to provide written informed consent
•Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg
•Likely to be available and willing to attend follow-up visits

Exclusion Criteria

•Angle closure glaucoma
•Secondary glaucomas
•Prior glaucoma procedures
•Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease