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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.
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: March 28, 2013
Last verified: March 2013
History of Changes
  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:

MedlinePlus related topics: Cataract Glaucoma
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: December 2015
Estimated Primary Completion Date: December 2015 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461291

Contacts
Contact: Gretchen Haig, BS, MBA 949-367-9600 ext 242 ghaig@glaukos.com
Contact: Jeff Wells, PharmD, MBA 949-367-9600 ext 227 jwells@glaukos.com

  Hide Study Locations
Locations
United States, Arkansas
Vold Vision Recruiting
Springdale, Arkansas, United States, 72762
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Steven Vold, MD            
United States, California
North Bay Eye Associates Recruiting
Petaluma, California, United States, 94954
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Jason Bacharach, MD            
North Bay Eye Associates Recruiting
Santa Rosa, California, United States, 95401
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: William Bartlett, MD            
United States, Colorado
Glaucoma Consultants of Colorado, DBA Specialty Eye Recruiting
Parker, Colorado, United States, 80134
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Randy Craven, MD            
United States, Connecticut
Ophthalmic Consultants of Connecticut Recruiting
Fairfield, Connecticut, United States, 06824
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Robert Noecker, MD            
United States, Florida
Cape Coral Eye Center Recruiting
Cape Coral, Florida, United States, 33904
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Farrell Tyson, MD            
Center for Excellence in Eye Care Recruiting
Miami, Florida, United States, 33176
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Carlos Buznego, MD            
International Eye Center Recruiting
Tampa, Florida, United States, 33603
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Bernard Perez, MD            
United States, Georgia
Eye Care Centers Management/Clayton Eye Center Recruiting
Morrow, Georgia, United States, 30260
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Harvey DuBiner, MD            
Sub-Investigator: Joon Kim, MD            
United States, Illinois
Chicago Eye Specialists Recruiting
Chicago, Illinois, United States, 60619
Contact: Vanessa Tasso, MA, MBA     949-367-9600        
Principal Investigator: Raj Goyal, MD            
United States, Kansas
Michael Stiles, MD Recruiting
Overland Park, Kansas, United States, 66213
United States, Massachusetts
D'Ambrosio Eye Care Recruiting
Lancaster, Massachusetts, United States, 01523
Contact: Vanessa Tasso, MA, MBA     949-367-9600        
Principal Investigator: Francis D'Ambrosio, MD            
United States, Michigan
Kresge Eye Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Vanessa Tasso, MA, MBA     949-367-9600        
Principal Investigator: Bret Hughes, MD            
United States, Minnesota
Minnesota Eye Consultants Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Thomas W Samuelson, MD            
United States, Missouri
Discover Vision Centers Recruiting
Independence, Missouri, United States, 64055
Contact: Vanessa Tasso, MA, MBA            
Principal Investigator: Douglas Dehning, MD            
Silverstein Eye Centers Recruiting
Kansas City, Missouri, United States, 64133
Contact: Vanessa Tasso, MA, MBA     949-367-9600        
Principal Investigator: Steven Silverstein, MD            
St. John's Medical Research Institute Recruiting
Springfield, Missouri, United States, 65807
Contact: Vanessa Tasso, MA, MBA     949-367-9600        
Principal Investigator: Joann Ohly, MD            
United States, New Jersey
Brar-Parekh Eye Associates Recruiting
Woodland Park, New Jersey, United States, 07424
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Jai Parekh, MD            
United States, New York
Glaucoma Consultants of the Capital Region Recruiting
Slingerlands, New York, United States, 12159
Contact: Vanessa Tasso     949-751-7039     vtasso@glaukos.com    
Principal Investigator: Steven Simmons, M.D.            
United States, Oklahoma
Dean McGee Eye Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: Steven Sarkisian, MD            
United States, South Carolina
Carolina Eyecare Physicians Recruiting
Mt. Pleasant, South Carolina, United States, 29464
Contact: Vanessa Tasso, MA, MBA     949-367-9600        
Principal Investigator: Kerry Solomon, MD            
Eastside Westside Research Center Recruiting
Spartanburg, South Carolina, United States, 29306
Contact: Vanessa Tasso     949-367-9600     vtasso@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: Vanessa Tasso     949-367-9600     vtasso@glaukos.com    
Principal Investigator: John Berdahl, MD            
United States, Texas
Texan Eye Recruiting
Austin, Texas, United States, 78731
Contact: Vanessa Tasso, MA, MBA     949-367-9600        
Principal Investigator: Robert Marquis, MD            
Sub-Investigator: Thomas Walters, MD            
United States, Washington
Spokane Eye Clinic Recruiting
Spokane, Washington, United States, 99204
Contact: Vanessa Tasso     949-367-9600     vtasso@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: March 28, 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
Cataract
 Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on June 18, 2013