Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor
Sponsor
Glaukos Corporation (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT05127551
Collaborator
(none)
0
2
35
Study Details
Study Description
Brief Summary
A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date
:
Jan 1, 2022
Anticipated Primary Completion Date
:
Jun 1, 2024
Anticipated Study Completion Date
:
Dec 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: iStent Infinite Subjects implanted with iStent Infinite system |
Device: iStent Infinite
Implantation of the iStent Infinite
|
| Active Comparator: Competitor Device Subject implanted with competitor device |
Device: Competitor Device
Implantation of competitor device
|
Outcome Measures
Primary Outcome Measures
- Change in Mean Diurnal Intraocular Pressure [Month 24]
Change in Mean Diurnal Intraocular Pressure from Baseline over time
Eligibility Criteria
Criteria
Ages Eligible for Study:
35 Years
to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Glaukos Corporation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Glaukos Corporation
ClinicalTrials.gov Identifier:
NCT05127551
Other Study ID Numbers:
- INFI-103-COMP
First Posted:
Nov 19, 2021
Last Update Posted:
Dec 8, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Glaukos Corporation
Additional relevant MeSH terms: