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: 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
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         
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         
Parkhurst-NuVision Recruiting
San Antonio, Texas, United States, 78229
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Gregory Parkhurst, 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
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on April 16, 2014