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A Clinical Trial Comparing the OMNI Surgical System to Standard Medical Treatment in Patients With Primary Open Angle Glaucoma

NCT06407973 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-01-29

No results posted yet for this study

Summary

A Randomized Clinical Trial of Ab Interno Canaloplasty and Trabeculotomy with the OMNI® Surgical System Compared to Standard Medical Treatment as a Standalone Procedure in Patients with Primary Open Angle Glaucoma (EVOLVE)

Conditions

  • Primary Open Angle Glaucoma

Interventions

DEVICE

OMNI Surgical System

The OMNI Surgical System is 510(k) cleared and indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma

DRUG

Latanoprost plus adjunctive glaucoma medication

* Latanoprost ophthalmic solution (0.005%) is a topical prostaglandin F2 analog used in the treatment of Glaucoma. * Adjunctive topical glaucoma medication(s) as selected by the Investigator

Sponsors & Collaborators

  • Sight Sciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-21
Primary Completion
2025-01-20
Completion
2025-01-20
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06407973 on ClinicalTrials.gov