Back to resultsiStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
Primary Purpose
Primary Open Angle Glaucoma (POAG)
Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
iStent inject surgery
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma (POAG)
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with primary open angle glaucoma (POAG)
- Subject on two ocular hypotensive medications
Exclusion Criteria:
- Traumatic, uveitic, neovascular, or angle closure glaucoma
- Fellow eye already enrolled
Sites / Locations
- Department of Ophthalmology - UNIFESP/ Hospital São Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iStent inject surgery
Arm Description
Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject
Outcomes
Primary Outcome Measures
IOP reduction at 12 and 24 months on same number or fewer medications
IOP reduction at 12 and 24 months on same number or fewer medications
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03478293
Brief Title
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
Official Title
A Prospective Evaluation of the Second Generation iStent Inject in Open-Angle Glaucoma Subjects on Two Preoperative Topical Ocular Hypotensive Medications
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Business Decision
Study Start Date
February 27, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)
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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications.
Detailed Description
The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of iStent inject in eyes of subjects with primary open-angle glaucoma previously on two anti-glaucoma medications. Outcomes will be evaluated at 12 and 24 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma (POAG)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Single (Outcomes Assessor)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iStent inject surgery
Arm Type
Experimental
Arm Description
Single-arm study. Intervention is micro-invasive glaucoma surgery (MIGS) to implant iStent inject
Intervention Type
Device
Intervention Name(s)
iStent inject surgery
Intervention Description
Micro-invasive glaucoma surgery (MIGS) to implant iStent inject
Primary Outcome Measure Information:
Title
IOP reduction at 12 and 24 months on same number or fewer medications
Description
IOP reduction at 12 and 24 months on same number or fewer medications
Time Frame
12 months and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Diagnosed with primary open angle glaucoma (POAG)
Subject on two ocular hypotensive medications
Exclusion Criteria:
Traumatic, uveitic, neovascular, or angle closure glaucoma
Fellow eye already enrolled
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerry Stephens, OD
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Department of Ophthalmology - UNIFESP/ Hospital São Paulo
City
São Paulo
ZIP/Postal Code
04023-62
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
iStent Inject in OAG Subjects on 2 Pre-op Topical Ocular Hypotensive Medications
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