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

  Show 35 Study Locations
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, Open-Angle
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 22, 2014