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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01461291
First received: October 25, 2011
Last updated: October 23, 2015
Last verified: October 2015

October 25, 2011
October 23, 2015
October 2011
July 2017   (final data collection date for primary outcome measure)
≥ 20% Reduction in Intraocular Pressure (IOP) [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
≥ 20% Reduction in IOP [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01461291 on ClinicalTrials.gov Archive Site
Diurnal IOP Reduction from Baseline [ Time Frame: Baseline and Month 24 ] [ Designated as safety issue: No ]
Diurnal IOP Reduction from Baseline [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery
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
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 vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Primary Open-angle Glaucoma
  • Device: iStent inject
    Implantation of two GTS400 stents using G2-M-IS iStent inject
  • Procedure: Cataract surgery
    Cataract surgery alone
  • Experimental: iStent inject
    Implantation of two GTS400 stents using G2-M-IS iStent inject
    Intervention: Device: iStent inject
  • Active Comparator: Cataract surgery
    Cataract surgery alone
    Intervention: Procedure: Cataract surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
October 2017
July 2017   (final data collection date for primary outcome measure)

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
Both
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01461291
GC-008
Yes
Not Provided
Not Provided
Glaukos Corporation
Glaukos Corporation
Not Provided
Not Provided
Glaukos Corporation
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP