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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2019
Source Ivantis, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial compares two implantable devices intended to lower the pressure inside the eye of glaucoma patients.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Hydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
iStent Trabecular Micro Bypass
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

Locations

Country Name City State
United States Contact Richard Hope at Ivantis Irvine California

Sponsors (1)

Lead Sponsor Collaborator
Ivantis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unmedicated IOP </= 19 mmHg at 12 Months Percentage of subjects with IOP 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 24 Months
Secondary Unmedicated IOP </= 18 mmHg at 12 Months Percentage of subjects with IOP 12 months
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