Safety and Effectiveness of the Hydrus Microstent (FRONTIER)

Alcon

Status: Terminated

Conditions: Open Angle Glaucoma; Primary Open Angle Glaucoma; Pigmentary Glaucoma; Pseudoexfoliation Glaucoma

Treatments: Device: Hydrus Microstent; Procedure: Ophthalmic surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT05198297

GLI314-C002 (Other Identifier)

CP 20-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

Hydrus Microstent

Experimental group

Description:

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.

Treatment:

Procedure: Ophthalmic surgery

Device: Hydrus Microstent