Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes (COMPARE)

November 25, 2019 updated by: Ivantis, Inc.

A Prospective, Multicenter, Randomized Comparison of the Hydrus to the iStent® for Lowering Intraocular Pressure in Primary Open Angle Glaucoma

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • Contact Richard Hope at Ivantis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrus Microstent
Patients randomized to the Hydrus Microstent .
Device: Hydrus Microstent
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Active Comparator: iStent Trabecular Micro Bypass
Patients randomized to the iStent Trabecular Micro Bypass
Device: iStent Trabecular Micro Bypass
Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unmedicated IOP </= 19 mmHg at 12 Months
Time Frame: 12 months
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percentage of Subjects Who Are Not Using Ocular Hypotensive Medications at 12 and 24 Months
Time Frame: 12 & 24 Months
The percentage of subjects who are not using ocular hypotensive medications at 12 and 24 months
12 & 24 Months
Mean Medication Use at 12 and 24 Months
Time Frame: 12 & 24 Months
The mean medication use at 12 and 24 months
12 & 24 Months
Unmedicated IOP </= 19 mmHg at 24 Months
Time Frame: 24 Months
Percentage of subjects with IOP </= 19 mmHg and without the use of ocular hypotensive medications at 24 months
24 Months
Unmedicated IOP </= 18 mmHg at 12 Months
Time Frame: 12 months
Percentage of subjects with IOP </= 18 mmHg and without the use of ocular hypotensive medications at 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivantis, Inc.

Investigators

  • Principal Investigator: Julian Garcia Feijoo, Prof. Med., Madrid, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Actual)

December 10, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-12-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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