Primary Open Angle Glaucoma Clinical Trial
— COMPAREOfficial title:
A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma
NCT number | NCT02023242 |
Other study ID # | CP-12-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2012 |
Est. completion date | January 2018 |
Verified date | November 2019 |
Source | Ivantis, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.
Status | Completed |
Enrollment | 152 |
Est. completion date | January 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 84 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Contact Richard Hope at Ivantis | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
Ivantis, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 months | |
Secondary | 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 | 12 & 24 Months | |
Secondary | Mean Medication Use at 12 and 24 Months | The mean medication use at 12 and 24 months | 12 & 24 Months | |
Secondary | 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 | 24 Months | |
Secondary | 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 | 12 months |
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