Back to resultsComparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes (COMPARE)
Primary Purpose
Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydrus Microstent
iStent Trabecular Micro Bypass
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary glaucoma, PG, Hydrus
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
- A phakic lens with BCVA of 20/30 or better
Exclusion Criteria:
- Forms of primary or secondary glaucoma not listed above
- Prior glaucoma surgery in the study eye
Sites / Locations
- Contact Richard Hope at Ivantis
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hydrus Microstent
iStent Trabecular Micro Bypass
Arm Description
Patients randomized to the Hydrus Microstent .
Patients randomized to the iStent Trabecular Micro Bypass
Outcomes
Primary Outcome Measures
Unmedicated IOP </= 19 mmHg at 12 Months
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months
Secondary Outcome Measures
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months
The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months
Mean Medication Use at 12 and 24 Months
The mean medication use at 12 and 24 months
Unmedicated IOP </= 19 mmHg at 24 Months
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 24 months
Unmedicated IOP </= 18 mmHg at 12 Months
Percentage of subjects with IOP </= 18 mmHg and without the use of ocular hypotensive medications at 12 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02023242
Brief Title
Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
Acronym
COMPARE
Official Title
A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ivantis, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
Detailed Description
This is a prospective, multicenter, single-masked, randomized clinical trial comparing the Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be conducted at regular intervals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma, Pigmentary Glaucoma
Keywords
Primary open angle glaucoma, POAG, Pseudoexfoliative glaucoma, PXG, Pigmentary glaucoma, PG, Hydrus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hydrus Microstent
Arm Type
Experimental
Arm Description
Patients randomized to the Hydrus Microstent .
Arm Title
iStent Trabecular Micro Bypass
Arm Type
Active Comparator
Arm Description
Patients randomized to the iStent Trabecular Micro Bypass
Intervention Type
Device
Intervention Name(s)
Hydrus Microstent
Intervention Description
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Intervention Type
Device
Intervention Name(s)
iStent Trabecular Micro Bypass
Intervention Description
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Primary Outcome Measure Information:
Title
Unmedicated IOP </= 19 mmHg at 12 Months
Description
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months
Description
The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months
Time Frame
12 & 24 Months
Title
Mean Medication Use at 12 and 24 Months
Description
The mean medication use at 12 and 24 months
Time Frame
12 & 24 Months
Title
Unmedicated IOP </= 19 mmHg at 24 Months
Description
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 24 months
Time Frame
24 Months
Title
Unmedicated IOP </= 18 mmHg at 12 Months
Description
Percentage of subjects with IOP </= 18 mmHg and without the use of ocular hypotensive medications at 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A diagnosis of primary open angle glaucoma (POAG), Pseudoexfoliative (PXG) glaucoma, or Pigmentary glaucoma (PG)
A phakic lens with BCVA of 20/30 or better
Exclusion Criteria:
Forms of primary or secondary glaucoma not listed above
Prior glaucoma surgery in the study eye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Garcia Feijoo, Prof. Med.
Organizational Affiliation
Madrid, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Contact Richard Hope at Ivantis
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
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