Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery

This study is currently recruiting participants.
Verified December 2013 by Glaukos Corporation
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01461278
First received: October 25, 2011
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 (hereinafter referred to as G3) 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 supra
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® Suprachoroidal Stent Model G3 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: 200
Study Start Date: October 2011
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cataract surgery and implantation of iStent supra Device: iStent supra
Cataract surgery and implantation of one iStent supra
Active Comparator: Cataract surgery 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 to 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: NCT01461278

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

Locations
United States, Arkansas
Vold Vision, PLLC Recruiting
Fayetteville, Arkansas, United States, 72704
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Steven Vold, MD         
United States, California
Inland Eye Specialist Recruiting
Hemet, California, United States, 92545
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Robert Sorenson, MD         
Sub-Investigator: R. Duncan Johnson, MD         
North Bay Eye Associates, Inc. Recruiting
Petaluma, California, United States, 94954
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Jason Bacharach, MD         
United States, Florida
Cape Coral Eye Center Recruiting
Cape Coral, Florida, United States, 33904
Contact: Jeff Wells    949-367-9600 ext 227    jwells@glaukos.com   
Principal Investigator: Farrell Tyson, MD         
The 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 Research Center, Inc. Recruiting
Tampa, Florida, United States, 33603
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Bernard Perez, 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 ext 227    jwells@glaukos.com   
Principal Investigator: John Berdahl, MD         
United States, Wisconsin
Eye Center of Racine and Kenosha LTD Recruiting
Racine, Wisconsin, United States, 53405
Contact: Jeff Wells    949-367-9600    jwells@glaukos.com   
Principal Investigator: Inder P Singh, MD         
Sponsors and Collaborators
Glaukos Corporation
  More Information

No publications provided

Responsible Party: Glaukos Corporation
ClinicalTrials.gov Identifier: NCT01461278     History of Changes
Other Study ID Numbers: GC-007
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
Cataract surgery
Suprachoroidal space
Suprachoroidal stent
iStent supra

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on April 23, 2014