Safety and Effectiveness of the Hydrus Microstent (FRONTIER)

The Hydrus® Microstent for Intraocular Pressure (IOP) Reduction in Mild to Moderate Open-Angle Glaucoma

The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent for lowering intraocular pressure (IOP) in pseudophakic patients with open-angle glaucoma for whom IOP is not sufficiently controlled on topical hypotensive medication and prior to incisional glaucoma surgery.

Study Overview

• Status: Terminated
• Conditions: Primary Open Angle Glaucoma; Open Angle Glaucoma; Pseudoexfoliation Glaucoma; Pigmentary Glaucoma
• Intervention / Treatment: Procedure: Ophthalmic surgery; Device: Hydrus Microstent

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.

A decision to terminate the study was made by the Sponsor arising from challenges with enrollment of the target study population, leading to suspension of enrollment and revision of the follow-up period to 12 months. The total duration of participation for each subject was approximately 13 months including the medication washout prior to implantation.

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

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bentonville, Arkansas, United States, 72712
      • Vold Vision PLLC
  • Florida
    • Zephyrhills, Florida, United States, 33542
      • The Eye Clinic of Florida
  • Michigan
    • Fraser, Michigan, United States, 48026
      • Fraser Eye Care Center
  • Ohio
    • Mason, Ohio, United States, 45040
      • Cincinnati Eye / Apex Eye
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Eye Centers Of Racine And Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 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;
• Age appropriate minimum central endothelial cell density;
• 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;
• Prior glaucoma surgery;
• Ocular hypertension;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hydrus Microstent; Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training. Only one eye (study eye) will be implanted.

Procedure: Ophthalmic surgery; Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia; Device: Hydrus Microstent; Minimally invasive glaucoma surgery device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects (Responders) with unmedicated DIOP greater than 6 mmHg and less than or equal to 21 mmHg with a reduction of greater than or equal to 20% from baseline and absence of secondary glaucoma surgery or loss of light perception	Intraocular pressure (IOP) will be measured using Goldmann tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure (DIOP). Baseline is defined as post ocular hypotensive medication washout and prior to Day 0, day of surgery. This is a co-primary endpoint. No hypothesis testing is prespecified.	Baseline, Month 12 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Unmedicated DIOP From Baseline to Month 12 and Absence of Secondary Glaucoma Surgery or Loss of Light Perception	IOP will be measured using Goldmann Applanation tonometry. Three separate IOP measurements will be taken over an 8-hour period and averaged together to achieve mean DIOP. Baseline will be defined as post ocular hypotensive medication washout and prior to Day 0, day of surgery. A negative change value represents an improvement. This is a co-primary endpoint. No hypothesis testing is prespecified.	Baseline, Month 12 postoperative

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Project Lead, Surgical, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

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 (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Ocular Hypertension; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome
• Other Study ID Numbers: GLI314-C002 (Alcon Research); CP 20-002 (Other Identifier: Ivantis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes