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NCT05127551 Clinical Trial

Clinical Study of Glaukos® Trabecular Micro-Bypass System Model iS3 Infinite Vs. Competitor

Glaucoma Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05127551
Other study ID # INFI-103-COMP
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 27, 2021
Est. completion date February 28, 2025

Study information
Verified date May 2024
Source Glaukos Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study of the iStent Infinite product in the treatment of open-angle glaucoma vs competitor

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 179
Est. completion date February 28, 2025
Est. primary completion date February 29, 2024
Accepts healthy volunteers No
Gender All
Age group 35 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• iStent Infinite
Implantation of the iStent Infinite
• Competitor Device
Implantation of competitor device

Locations
Country Name City State
Canada Glaukos Investigator Sites Montréal Qubec

Sponsors (1)
Lead Sponsor Collaborator
Glaukos Corporation

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Mean Diurnal Intraocular Pressure Change in Mean Diurnal Intraocular Pressure from Baseline over time Month 24
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