One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

Sponsor

Glaukos Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01517477

Collaborator

(none)

251

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma (POAG)	Device: iStent Device: iStent Device: iStent	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

251 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: First Arm: One iStent Device: One iStent	Device: iStent Implantation of One iStent through a small temporal clear corneal incision.
Experimental: Second Arm: Two iStents Device: Two iStent devices	Device: iStent Implantation of Two iStents through a small temporal clear corneal incision
Experimental: Third Arm: Three iStents Device: Three iStent devices	Device: iStent Implantation of Three iStents through a small temporal clear corneal incision

Arm

Intervention/Treatment

Experimental: First Arm: One iStent

Device: One iStent

Device: iStent

Implantation of One iStent through a small temporal clear corneal incision.

Experimental: Second Arm: Two iStents

Device: Two iStent devices

Device: iStent

Implantation of Two iStents through a small temporal clear corneal incision

Experimental: Third Arm: Three iStents

Device: Three iStent devices

Device: iStent

Implantation of Three iStents through a small temporal clear corneal incision

Outcome Measures

Primary Outcome Measures

Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline [12 Months]

Secondary Outcome Measures

Mean diurnal IOP <18 mmHg at month 12 [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	S.V. Malayan's Ophthalmology Centre	Yerevan		Armenia	375108

Sponsors and Collaborators

Glaukos Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Glaukos Corporation

ClinicalTrials.gov Identifier:

NCT01517477

Other Study ID Numbers:

GCF-033

First Posted:

Jan 25, 2012

Last Update Posted:

Mar 9, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by Glaukos Corporation

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Study Results

No Results Posted as of Mar 9, 2018