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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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:
Cataract
Glaucoma
Glaucoma, Open-Angle
Eye Diseases
Lens Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on October 30, 2014