Clinical trial NCT05198297: Safety and Effectiveness of the Hydrus Microstent
Official title: The Hydrus® Microstent for Intraocular Pressure (IOP) Reduction in Mild to Moderate Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Open Angle Glaucoma
Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Pigmentary Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 33
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Month 12 postoperative
Secondary outcomes:
measure: Mean Change in Unmedicated DIOP From Baseline to Month 12 and Absence of Secondary Glaucoma Surgery or Loss of Light Perception
timeFrame: Baseline, Month 12 postoperative
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Vold Vision PLLC
state: Arkansas
city: Zephyrhills
country: United States
facility: The Eye Clinic of Florida
state: Florida
city: Fraser
country: United States
facility: Fraser Eye Care Center
state: Michigan
city: Mason
country: United States
facility: Cincinnati Eye / Apex Eye
state: Ohio
city: Kenosha
country: United States
facility: Eye Centers Of Racine And Kenosha
state: Wisconsin
Study officials:
affiliation: Alcon Research, LLC
name: Sr. Clinical Project Lead, Surgical
role: STUDY_DIRECTOR
References: