Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor
August 13, 2024 updated by: Glaukos Corporation
A Prospective, Randomized, Controlled, Comparitive Multicenter Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite® vs Competitor in Adult Subjects With Primary Open-Angle Glaucoma (POAG)
A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
179
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Qubec
-
Montréal, Qubec, Canada, H1A 0A1
- Glaukos Investigator Sites
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of Primary Open-Angle Glaucoma (POAG) or Secondary Pseudoexfoliative Glacoma (PEXG) or Secondary Pigmentary Glaucoma (PG)
Exclusion Criteria:
- Any other type of glaucoma including, but not limited to: traumatic glaucoma, angle recession glaucoma, uveitic glaucoma, neovascular glaucoma, angle closure glaucoma (ACG) and glaucoma associated with vascular disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: iStent Infinite
Subjects implanted with iStent Infinite system
|
Implantation of the iStent Infinite
|
|
Active Comparator: Competitor Device
Subject implanted with competitor device
|
Implantation of competitor device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mean Diurnal Intraocular Pressure
Time Frame: Month 24
|
Change in Mean Diurnal Intraocular Pressure from Baseline over time
|
Month 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 27, 2021
Primary Completion (Actual)
February 29, 2024
Study Completion (Estimated)
February 28, 2025
Study Registration Dates
First Submitted
November 9, 2021
First Submitted That Met QC Criteria
November 18, 2021
First Posted (Actual)
November 19, 2021
Study Record Updates
Last Update Posted (Actual)
August 15, 2024
Last Update Submitted That Met QC Criteria
August 13, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INFI-103-COMP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.