Back to resultsGlaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Primary Purpose
Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iStent Infinite
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary open-angle glaucoma Phakic or pseudophakic Age 35 years or older Exclusion Criteria: Traumatic, uveitic, neovascular, angle-closure glaucoma or glaucoma associated with vascular disorders Active corneal inflammation or edema Retinal disorders not associated with glaucoma
Sites / Locations
- Glaukos Investigator SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iStent Infinite
Arm Description
iStent Infinite Trabecular Micro-Bypass System
Outcomes
Primary Outcome Measures
Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT06057051
First Posted
September 21, 2023
Last Updated
September 26, 2023
Sponsor
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT06057051
Brief Title
Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Official Title
A Prospective, Multicenter Study of the Glaukos® iStent Infinite Trabecular Micro-Bypass System Model iS3 in Subjects With Mild to Moderate Primary Open-angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2027 (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
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective, multicenter, single-arm study of the iStent infinite in adult pseudophakic or phakic subjects with mild to moderate primary open angle glaucoma who have not failed conventional medical and surgical treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
245 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iStent Infinite
Arm Type
Experimental
Arm Description
iStent Infinite Trabecular Micro-Bypass System
Intervention Type
Device
Intervention Name(s)
iStent Infinite
Intervention Description
iStent Infinite Trabecular Micro-Bypass System
Primary Outcome Measure Information:
Title
Mean Diurnal Intraocular Pressure (IOP) 12-Month reduction ≥ 20% from Baseline
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary open-angle glaucoma
Phakic or pseudophakic
Age 35 years or older
Exclusion Criteria:
Traumatic, uveitic, neovascular, angle-closure glaucoma or
glaucoma associated with vascular disorders
Active corneal inflammation or edema
Retinal disorders not associated with glaucoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dari Parizadeh
Phone
949-481-0575
Email
dparizadeh@glaukos.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kerry Stephens
Phone
949-481-8057
Email
kstephens@glaukos.com
Facility Information:
Facility Name
Glaukos Investigator Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dari Parizadeh
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Glaukos® iStent Infinite Trabecular Micro-Bypass System in Subjects With Mild to Moderate Primary Open-angle Glaucoma
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