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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
  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:


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

  Hide Study Locations
Locations
United States, Arizona
Glendale, Arizona, United States, 85306
United States, Arkansas
Fayetteville, Arkansas, United States, 72704
United States, California
La Jolla, California, United States, 92037
Murrieta, California, United States, 92562
Petaluma, California, United States, 94954
Redding, California, United States, 96002
Santa Rosa, California, United States, 95401
United States, Colorado
Fort Collins, Colorado, United States, 80525
Parker, Colorado, United States, 80134
United States, Connecticut
Fairfield, Connecticut, United States, 06824
United States, Florida
Cape Coral, Florida, United States, 33904
Miami, Florida, United States, 33176
Sarasota, Florida, United States, 34239
Tampa, Florida, United States, 33603
United States, Georgia
Morrow, Georgia, United States, 30260
United States, Illinois
Chicago, Illinois, United States, 60619
Homewood, Illinois, United States, 60430
United States, Kansas
Overland Park, Kansas, United States, 66213
United States, Maryland
Baltimore, Maryland, United States, 21287
Bowie, Maryland, United States, 20716
United States, Massachusetts
Lancaster, Massachusetts, United States, 01523
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Bloomington, Minnesota, United States, 55431
United States, Missouri
Independence, Missouri, United States, 64055
Kansas City, Missouri, United States, 64133
Springfield, Missouri, United States, 65807
St. Louis, Missouri, United States, 63131
United States, New Jersey
South Orange, New Jersey, United States, 07079
Vineland, New Jersey, United States, 08361
United States, New York
Slingerlands, New York, United States, 12159
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
West Mifflin, Pennsylvania, United States, 15122
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
Spartanburg, South Carolina, United States, 29306
United States, South Dakota
Sioux Falls, South Dakota, United States, 57117
United States, Tennessee
Memphis, Tennessee, United States, 38120
United States, Texas
Austin, Texas, United States, 78731
Fort Worth, Texas, United States, 76102
San Antonio, Texas, United States, 78229
United States, Virginia
Norfolk, Virginia, United States, 23502
Roanoke, Virginia, United States, 24016
United States, Washington
Spokane, Washington, United States, 99204
United States, Wisconsin
Racine, Wisconsin, United States, 53405
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
Cataract
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on December 09, 2016