Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
A Prospective, Randomized, Controlled, Parallel Groups, Multicenter Clinical Investigation Of The Trabecular Micro-Bypass Stent Model GTS400 In Conjunction With Cataract Surgery
1 other identifier
interventional
62
0 countries
N/A
Brief Summary
To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2007
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
March 6, 2014
CompletedMarch 6, 2014
February 1, 2014
4.9 years
July 23, 2008
April 18, 2013
February 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Month 12 Intraocular Pressure ≤ 18 mmHg Without Topical Hypotensive Medications
Percent reaching this endpoint
12 months
Other Outcomes (1)
Number of Ocular Hypotensive Medications by Visit
12 months
Study Arms (2)
1
ACTIVE COMPARATORTreatment Group (Group 1): Glaukos Trabecular Micro-Bypass Stent Model GTS400; implantation in conjunction with cataract surgery
2
PLACEBO COMPARATORControl Group (Group 2): Cataract surgery only
Interventions
ab interno trabecular bypass stent surgery
Eligibility Criteria
You may qualify if:
- Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery
- Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There are no limitations and caveats to report
Results Point of Contact
- Title
- Jeff Wells. Sr VP, Clinical, Regulatory, and Quality Affairs
- Organization
- Glaukos
Study Officials
- STUDY DIRECTOR
Head of Clinical Affairs
Glaukos Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2008
First Posted
July 25, 2008
Study Start
March 1, 2007
Primary Completion
February 1, 2012
Study Completion
August 1, 2012
Last Updated
March 6, 2014
Results First Posted
March 6, 2014
Record last verified: 2014-02