Back to resultsClinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor
Primary Purpose
Glaucoma, Glaucoma, Open-Angle
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
iStent Infinite
Competitor Device
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, MIGS
Eligibility Criteria
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
Sites / Locations
- Glaukos Investigator Sites
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
iStent Infinite
Competitor Device
Arm Description
Subjects implanted with iStent Infinite system
Subject implanted with competitor device
Outcomes
Primary Outcome Measures
Change in Mean Diurnal Intraocular Pressure
Change in Mean Diurnal Intraocular Pressure from Baseline over time
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05127551
Brief Title
Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 27, 2021 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open-Angle
Keywords
Glaucoma, MIGS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iStent Infinite
Arm Type
Active Comparator
Arm Description
Subjects implanted with iStent Infinite system
Arm Title
Competitor Device
Arm Type
Active Comparator
Arm Description
Subject implanted with competitor device
Intervention Type
Device
Intervention Name(s)
iStent Infinite
Intervention Description
Implantation of the iStent Infinite
Intervention Type
Device
Intervention Name(s)
Competitor Device
Intervention Description
Implantation of competitor device
Primary Outcome Measure Information:
Title
Change in Mean Diurnal Intraocular Pressure
Description
Change in Mean Diurnal Intraocular Pressure from Baseline over time
Time Frame
Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Glaukos Investigator Sites
City
Montréal
State/Province
Qubec
ZIP/Postal Code
H1A 0A1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor
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