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

NCT ID: NCT06407973

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-21
• Study Completion Date: 2025-01-20

Brief 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)

Detailed Description

This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS as a standalone procedure in patients with POAG.

Conditions

Primary Open Angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical (OMNI Surgical System (OSS))

Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.

Group Type: ACTIVE_COMPARATOR

OMNI Surgical System

Intervention Type: DEVICE

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

Standard Medical Care (SMC)

Standard Medical Care with Latanoprost and one or two adjunctive glaucoma medications at the discretion of the Principal Investigator

Group Type: ACTIVE_COMPARATOR

Latanoprost plus adjunctive glaucoma medication

Intervention Type: DRUG

• 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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: DRUG

Other Intervention Names

OMNI

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects, 45 years or older.

2. History of uncomplicated cataract surgery and posterior chamber intraocular lens (IOL) implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit (pseudophakic subjects), OR, phakic and no anticipated need for cataract surgery over the study duration.

3. Under treatment with a topical prostaglandin F2 analog (e.g. latanoprost, travoprost, bimatoprost, tafluprost) either as monotherapy or in combination with one (1) adjunctive medication for a minimum of 6 weeks prior to the Screening visit.

4. Intraocular pressure (IOP) at the Screening visit of >18 and not exceeding 36 mmHg.

5. Diagnosed with primary open angle glaucoma (POAG).

Exclusion Criteria

1. Any of the following prior ocular procedures:

• Laser trabeculoplasty ≤180 days prior to baseline
• Durysta ≤12 months prior to baseline unless failure is documented and topical medication including a prostaglandin analog is in use as per Inclusion criterion # 3.
• Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device; or
• Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe)
• Retinal laser procedure ≤3 months prior to baseline

2. Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)

3. Forms of glaucoma other than POAG including but not limited to: Pigmentary, pseudoexfoliative, acute angle closure, normal tension, pre-perimetric, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subject's medical record.

4. Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sight Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

North Bay Eye Associates

Petaluma, California, United States

University Eye Specialists

Maryville, Tennessee, United States

Countries

United States

Other Identifiers

09074

Identifier Type: -

Identifier Source: org_study_id