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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 currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Glaukos Corporation
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01461291
First received: October 25, 2011
Last updated: December 16, 2013
Last verified: March 2013
  Purpose

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.


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 2016
Estimated Primary Completion Date: July 2016 (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

  Eligibility

Ages Eligible for Study:   45 Years and older
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

Contacts
Contact: Jeff Wells, PharmD, MBA 949-367-9600 ext 227 jwells@glaukos.com

  Hide Study Locations
Locations
United States, Arizona
George R. Reiss, MD, PC Recruiting
Glendale, Arizona, United States, 85306
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: George R Reiss, MD         
United States, Arkansas
Vold Vision Recruiting
Fayetteville, Arkansas, United States, 72704
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Steven Vold, MD         
United States, California
Scripps Clinical Research Services Recruiting
La Jolla, California, United States, 92037
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Quang Nguyen, MD         
North Bay Eye Associates Recruiting
Petaluma, California, United States, 94954
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Jason Bacharach, MD         
North Bay Eye Associates Recruiting
Santa Rosa, California, United States, 95401
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: William Bartlett, MD         
United States, Colorado
Eye Center of Northern Colorado, PC Recruiting
Fort Collins, Colorado, United States, 80525
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Kent Bashford, MD         
Glaucoma Consultants of Colorado, DBA Specialty Eye Recruiting
Parker, Colorado, United States, 80134
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: C. Starck Johnson, MD         
United States, Connecticut
Ophthalmic Consultants of Connecticut Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Robert Noecker, MD         
United States, Florida
Cape Coral Eye Center Recruiting
Cape Coral, Florida, United States, 33904
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Farrell Tyson, MD         
Center for Excellence in Eye Care Recruiting
Miami, Florida, United States, 33176
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Carlos Buznego, MD         
International Eye Center Recruiting
Tampa, Florida, United States, 33603
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Bernard Perez, MD         
United States, Georgia
Eye Care Centers Management/Clayton Eye Center Recruiting
Morrow, Georgia, United States, 30260
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Harvey DuBiner, MD         
United States, Illinois
Chicago Eye Specialists Recruiting
Chicago, Illinois, United States, 60619
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Raj Goyal, MD         
United States, Kansas
Stiles Eyecare Excellence and Glaucoma Institute Recruiting
Overland Park, Kansas, United States, 66213
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Michael Stiles, MD         
United States, Maryland
Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Michael Boland, MD         
United States, Massachusetts
D'Ambrosio Eye Care Recruiting
Lancaster, Massachusetts, United States, 01523
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Francis D'Ambrosio, MD         
United States, Michigan
Kresge Eye Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Bret Hughes, MD         
United States, Minnesota
Minnesota Eye Consultants Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Thomas W Samuelson, MD         
United States, Missouri
Discover Vision Centers Recruiting
Independence, Missouri, United States, 64055
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Douglas Dehning, MD         
Silverstein Eye Centers Recruiting
Kansas City, Missouri, United States, 64133
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Steven Silverstein, MD         
St. John's Medical Research Institute Recruiting
Springfield, Missouri, United States, 65807
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Joann Ohly, MD         
Ophthalmology Consultants Recruiting
St. Louis, Missouri, United States, 63131
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Joseph Gira, MD         
United States, New Jersey
Eye Associates Recruiting
Vineland, New Jersey, United States, 08361
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Sydney Tyson, MD         
United States, New York
Glaucoma Consultants of the Capital Region Recruiting
Slingerlands, New York, United States, 12159
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Steven Simmons, M.D.         
United States, Oklahoma
Dean McGee Eye Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Steven Sarkisian, MD         
United States, Pennsylvania
Associates in Ophthalmology LLT Recruiting
West Mifflin, Pennsylvania, United States, 15122
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: John Nairn, MD         
United States, South Carolina
Carolina Eyecare Physicians Recruiting
Mt. Pleasant, South Carolina, United States, 29464
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Kerry Solomon, MD         
Eastside Westside Research Center Recruiting
Spartanburg, South Carolina, United States, 29306
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Lawrence Roel, MD         
United States, South Dakota
Vance Thompson Vision/Sanford Health-USD Recruiting
Sioux Falls, South Dakota, United States, 57117
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: John Berdahl, MD         
United States, Texas
Texan Eye Recruiting
Austin, Texas, United States, 78731
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Robert Marquis, MD         
Ophthalmology Associates Recruiting
Fort Worth, Texas, United States, 76102
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Brian Flowers, MD         
Parkhurst-NuVision Recruiting
San Antonio, Texas, United States, 78229
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Gregory Parkhurst, MD         
R and R Eye Research, LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: William Flynn, MD         
United States, Virginia
Virginia Eye Care Recruiting
Norfolk, Virginia, United States, 23502
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Constance Okeke, MD         
United States, Washington
Spokane Eye Clinic Recruiting
Spokane, Washington, United States, 99204
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Barbara Smit, MD         
Sponsors and Collaborators
Glaukos Corporation
  More Information

No publications provided

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: December 16, 2013
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
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 27, 2014