Multicenter Investigation of the Glaukos® Suprachoroidal Stent Model G3 In Conjunction With Cataract Surgery
This study is currently recruiting participants.
Verified March 2013 by Glaukos Corporation
Sponsor:
Glaukos Corporation
Information provided by (Responsible Party):
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT01461278
First received: October 25, 2011
Last updated: March 28, 2013
Last verified: March 2013
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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: | January 2015 |
| Estimated Primary Completion Date: | December 2014 (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: Gretchen Haig, BS, MBA | 949-367-9600 ext 242 | ghaig@glaukos.com |
| Contact: Jeff Wells, PharmD, MBA | 949-367-9600 ext 227 | jwells@glaukos.com |
Locations
| United States, Arkansas | |
| Vold Vision | Recruiting |
| Springdale, Arkansas, United States, 72762 | |
| Contact: Gretchen Haig 949-367-9600 ext 242 ghaig@glaukos.com | |
| Principal Investigator: Steven Vold, MD | |
| United States, California | |
| North Bay Eye Associates | Recruiting |
| Petaluma, California, United States, 94954 | |
| Contact: Gretchen Haig 949-367-9600 ext 242 ghaig@glaukos.com | |
| Principal Investigator: Jason Bacharach, MD | |
| United States, Florida | |
| Farrell Tyson, MBA | Recruiting |
| Cape Coral, Florida, United States, 33904 | |
| Center for Excellence in Eye Care | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Gretchen Haig 949-367-9600 ext 242 ghaig@glaukos.com | |
| Principal Investigator: Carlos Buznego, MD | |
| International Eye Center | Recruiting |
| Tampa, Florida, United States, 33603 | |
| Contact: Gretchen Haig 949-367-9600 ext 242 ghaig@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: Gretchen Haig 949-367-9600 ext 242 ghaig@glaukos.com | |
| Principal Investigator: John Berdahl, 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: | March 28, 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 May 22, 2013