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

• ClinicalTrials.gov Identifier: NCT01461278
• Recruitment Status: Unknown
• First Posted: October 28, 2011
• Last Update Posted: March 8, 2019
• Sponsor: Glaukos Corporation
• Information provided by (Responsible Party): Glaukos Corporation

Tracking Information

• First Submitted Date: October 25, 2011
• First Posted Date: October 28, 2011
• Last Update Posted Date: March 8, 2019
• Study Start Date: October 2011
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 27, 2011): ≥ 20% Reduction in Intraocular Pressure (IOP) [ Time Frame: Baseline and Month 24 ]
• Original Primary Outcome Measures (submitted: October 26, 2011): ≥ 20% Reduction in IOP [ Time Frame: Baseline to Month 24 ]
• Current Secondary Outcome Measures (submitted: October 27, 2011): Diurnal IOP Reduction from Baseline [ Time Frame: Baseline and Month 24 ]
• Original Secondary Outcome Measures (submitted: October 26, 2011): Diurnal IOP Reduction from Baseline [ Time Frame: Baseline to Month 24 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery
• 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
• Brief Summary: Evaluate the safety and efficacy of the Glaukos® Suprachoroidal Stent Model G3 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.
• Detailed Description: This is an IDE trial to 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Primary Open-angle Glaucoma

Intervention

• Device: iStent supra
  Cataract surgery and implantation of one iStent supra
• Procedure: Cataract surgery
  Cataract surgery alone

Study Arms

• Experimental: Cataract surgery plus iStent supra
  Interventions:

  • Device: iStent supra
  • Procedure: Cataract surgery
• Active Comparator: Cataract surgery
  Intervention: Procedure: Cataract surgery

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 16, 2015): 1200
• Original Estimated Enrollment (submitted: October 26, 2011): 200
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01461278
• Other Study ID Numbers: GC-007
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Glaukos Corporation
• Study Sponsor: Glaukos Corporation
• Collaborators: Not Provided

Investigators

• Study Chair: Kerry Stephens, O.D.; Glaukos Corporation

• PRS Account: Glaukos Corporation
• Verification Date: March 2019