Safety & Effectiveness Study of the Hydrus Microstent for Lowering IOP in Glaucoma Patients Undergoing Cataract Surgery (HORIZON)

February 15, 2021 updated by: Ivantis, Inc.

The Safety and Effectiveness of the Hydrus Aqueous Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery, A Prospective, Multicenter, Randomized, Controlled Clinical Trial

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1143

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • Quebec
      • Boisbriand, Quebec, Canada
  • Germany
      • Mainz, Germany
  • Italy
      • Parma, Italy
  • Mexico
      • Tijuana, Mexico
  • Philippines
      • Manila, Philippines
  • Poland
      • Warsaw, Poland
  • Spain
      • Madrid, Spain
      • Zaragoza, Spain
  • United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Fayetteville, Arkansas, United States
    • California
      • La Jolla, California, United States
      • Orange, California, United States
      • Sacramento, California, United States
    • Colorado
      • Fort Collins, Colorado, United States
      • Parker, Colorado, United States
    • Florida
      • Bradenton, Florida, United States
      • Fort Myers, Florida, United States
      • Ocala, Florida, United States
    • Iowa
      • Sioux City, Iowa, United States
    • Kansas
      • Garden City, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Massachusetts
      • Sandwich, Massachusetts, United States
    • Minnesota
      • Bloomington, Minnesota, United States
    • Missouri
      • Chesterfield, Missouri, United States
    • North Carolina
      • Wilmington, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Mason, Ohio, United States
    • Tennessee
      • Maryville, Tennessee, United States
    • Texas
      • Austin, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Wisconsin
      • Racine, Wisconsin, United States

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • An operable age-related cataract
  • A diagnosis of POAG treated with 1 to 4 hypotensive medications
  • Medicated IOP ≤ 31 mmHg
  • Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg

Exclusion Criteria:

  • Congenital or developmental glaucoma
  • Previous argon laser trabeculoplasty
  • Ab-interno or ab-externo device implanted in or through Schlemm's Canal
  • Use of oral hypotensive medication for glaucoma for treatment of fellow 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydrus Aqueous Implant (Treatment)
Cataract surgery plus Hydrus Aqueous Implant
Device: Hydrus Aqueous Implant
The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
Active Comparator: Cataract Surgery (Control)
Cataract surgery only
Procedure: Cataract surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
Time Frame: Baseline and 24 months
Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.
Baseline and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.
Time Frame: Baseline and 24 months
Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.
Baseline and 24 months

Collaborators and Investigators

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

Sponsor

Ivantis, Inc.

Investigators

  • Principal Investigator: Alan Crandall, MD, The Eye Institute of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 24, 2012

First Posted (Estimate)

February 27, 2012

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-11-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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