[Trial of device that is not approved or cleared by the U.S. FDA] (FRONTIER)

February 5, 2024 updated by: [Redacted]
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent for lowering intraocular pressure in pseudophakic patients with open-angle glaucoma for whom intraocular pressure (IOP) is not adequately controlled on topical hypotensive medications. This study will enroll subjects with prior uncomplicated cataract surgery and intraocular lens (IOL) implantation.

Study Overview

Status

Withheld

Conditions

Intervention / Treatment

Detailed Description

Qualified subjects will undergo ocular hypotensive medication washout prior to implantation with the Hydrus Microstent. Following implantation on Day 0, subjects will attend 8 scheduled postoperative visits: Day 1, Week 1, Month 1, Month 3, Month 6, Month 12, Month 18, and Month 24.

This study was initiated by Ivantis, Inc. Ivantis was acquired by Alcon Research, and Alcon assumed sponsorship of the study in November 2022.

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

  • Germany
      • Bonn, Germany, D-53127
        • Not yet recruiting
        • Alcon Investigator 8204
  • Italy
      • Torino, Italy, 10126
        • Not yet recruiting
        • Alcon Investigator 8199
  • Philippines
      • Makati City, Philippines, 1200
        • Not yet recruiting
        • Alcon Investigator 8196
  • Spain
      • Zaragoza, Spain, 50009
        • Not yet recruiting
        • Alcon Investigator 8202
  • United Kingdom
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH39HA
        • Not yet recruiting
        • Alcon Investigator 7452
    • West Sussex
      • East Grinstead, West Sussex, United Kingdom, RH19 3DZ
        • Not yet recruiting
        • Alcon Investigator 8205
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Recruiting
        • Alcon Investigator 7923
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Alcon Investigator 8201
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Recruiting
        • Alcon Investigator 4734
      • Rogers, Arkansas, United States, 72756
        • Recruiting
        • Alcon Investigator 8197
    • California
      • Pasadena, California, United States, 91105
        • Not yet recruiting
        • Alcon Investigator 8200
    • Florida
      • Zephyrhills, Florida, United States, 33542
        • Recruiting
        • Alcon Investigator 8203
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Recruiting
        • Alcon Investigator 8206
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Not yet recruiting
        • Alcon Investigator 8195
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Alcon Investigator 6723
    • Michigan
      • Fraser, Michigan, United States, 48026
        • Recruiting
        • Alcon Investigator 7931
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Alcon Investigator 6725
      • Mason, Ohio, United States, 45040
        • Recruiting
        • Alcon Investigator 4755
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Recruiting
        • Alcon Investigator 8207
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Alcon Investigator 8198
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Alcon Investigator 5231
      • Fort Worth, Texas, United States, 76102
        • Recruiting
        • Alcon Investigator 3113
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Alcon Investigator 5471

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

43 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Early or moderate glaucomatous optic nerve damage;
  • Uncomplicated cataract surgery with well centered posterior chamber IOL greater than or equal to 365 days prior to the screening visit;
  • Inadequately controlled IOP;
  • Shaffer angle grade III-IV in all four quadrants;
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Diagnosis of acute angle closure, chronic angle closure, or congenital, malignant, or developmental glaucoma;
  • Requires oral hypotensive medications;
  • Shallow or flat anterior chamber;
  • Other protocol-defined exclusion criteria may apply.

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?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hydrus Microstent
Hydrus Microstent implanted in the eye
Device: Hydrus Microstent
Crescent-shaped nitinol device intended as a permanent implant to provide an outflow pathway for aqueous humor. The device is placed through the trabecular meshwork into Schlemm's canal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with an unmedicated diurnal interocular pressure (DIOP) of >6 mmHg and ≤21 mmHg with a reduction of ≥20% vs. baseline in the absence of secondary glaucoma surgery or loss of light perception (12-month responder rate)
Time Frame: Baseline, Month 12 postoperative
IOP will be measured at three timepoints during the day (8:00 AM, 12:00 PM, and 4:00 PM) using Goldmann tonometry. Each time IOP is measured, two measurements will be taken unless they differ by more than 2 mmHg, in which case a third measurement will be taken. The mean of two measurements (or the median value in the case of three IOP measurements) will be used for data analysis. Baseline is defined as post ocular hypotensive medication washout and prior to Day 0, day of surgery.
Baseline, Month 12 postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change (mmHg) from baseline in unmedicated DIOP at Month 12
Time Frame: Baseline, Month 12 postoperative
IOP will be measured at three timepoints during the day (8:00 AM, 12:00 PM, and 4:00 PM) using Goldmann tonometry. Each time IOP is measured, two measurements will be taken unless they differ by more than 2 mmHg, in which case a third measurement will be taken. The mean of two measurements (or the median value in the case of three IOP measurements) will be used for data analysis. Baseline is defined as post ocular hypotensive medication washout and prior to Day 0, day of surgery.
Baseline, Month 12 postoperative

Collaborators and Investigators

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

Sponsor

[Redacted]

Investigators

  • Study Director: Clinical Project Lead, CDMA Surgical, Alcon Research, LLC

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

December 13, 2021

Primary Completion

May 1, 2025

Study Completion

May 1, 2026

Study Registration Dates

First Submitted

January 3, 2022

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP 20-002
  • GLI314-C002 (Other Identifier: Alcon Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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