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

NCT06407973 | Terminated Phase 4 FDA Drug FDA Device

• 1 other identifier: 09074
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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)

Conditions

Primary Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• Subjects with a ≥ 20% reduction

  Proportion of subjects with a ≥ 20% reduction from medicated baseline in mean diurnal IOP (DIOP) at 12 months post-operatively

  12 months

Secondary Outcomes (5)

• Diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive)

  12 months

• Number of Ocular Hypotensive Medications

  12 months

• Tear break-up time (TBUT)

  12 months

• Corneal or conjunctival staining

  12 months

• OSDI score

  12 months

Study Arms (2)

Surgical (OMNI Surgical System (OSS))

ACTIVE COMPARATOR

Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.

Device: OMNI Surgical System

Standard Medical Care (SMC)

ACTIVE COMPARATOR

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

Drug: Latanoprost plus adjunctive glaucoma medication

Interventions

OMNI Surgical System 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

Also known as: OMNI

Surgical (OMNI Surgical System (OSS))

Latanoprost plus adjunctive glaucoma medication 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

Standard Medical Care (SMC)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects, 45 years or older.
• 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.
• 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.
• Intraocular pressure (IOP) at the Screening visit of \>18 and not exceeding 36 mmHg.
• Diagnosed with primary open angle glaucoma (POAG).

You may not qualify if:

• Any of the following prior ocular procedures:
• Laser trabeculoplasty ≤180 days prior to baseline
• 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
• Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP, CPC,etc.)
• 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.
• 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

Sponsors & Collaborators

• Sight Sciences, Inc.: lead

Study Sites (2)

North Bay Eye Associates

Petaluma, California, 94954, United States

Location

University Eye Specialists

Maryville, Tennessee, 37803, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled open label

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: August 21, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)