Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Glaukos Corporation

ClinicalTrials.gov Identifier:

NCT01461291

First received: October 25, 2011

Last updated: October 23, 2015

Last verified: October 2015

History of Changes

Purpose

Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Condition	Intervention	Phase
Primary Open-angle Glaucoma	Device: iStent inject Procedure: Cataract surgery	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

Further study details as provided by Glaukos Corporation:

Primary Outcome Measures:

≥ 20% Reduction in Intraocular Pressure (IOP) [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Diurnal IOP Reduction from Baseline [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]


Estimated Enrollment:	1200
Study Start Date:	October 2011
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	July 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: iStent inject Implantation of two GTS400 stents using G2-M-IS iStent inject	Device: iStent inject Implantation of two GTS400 stents using G2-M-IS iStent inject
Active Comparator: Cataract surgery Cataract surgery alone	Procedure: Cataract surgery Cataract surgery alone

Detailed Description:

The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Eligibility


Ages Eligible for Study:	45 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mild to moderate open-angle glaucoma
Characteristics consistent with mild/moderate glaucoma
Use of one (1) to three (3) medications at time of screening exam

Exclusion Criteria:

Pigmentary or pseudoexfoliative glaucoma
Prior incisional glaucoma surgery

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461291

Show 43 Study Locations

Sponsors and Collaborators

Glaukos Corporation

More Information


Responsible Party:	Glaukos Corporation
ClinicalTrials.gov Identifier:	NCT01461291 History of Changes
Other Study ID Numbers:	GC-008
Study First Received:	October 25, 2011
Last Updated:	October 23, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Glaukos Corporation:


Primary open-angle glaucoma POAG Trabecular meshwork iStent inject

Additional relevant MeSH terms:


Glaucoma Glaucoma, Open-Angle Cataract	Ocular Hypertension Eye Diseases Lens Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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