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

Phase 4

Terminated

• Conditions: Primary Open Angle Glaucoma
• Interventions: Device: OMNI Surgical System; Drug: Latanoprost plus adjunctive glaucoma medication

• Registration Number: NCT06407973
• Lead Sponsor: Sight Sciences, Inc.

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.

Study Timeline

• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Study Start: 2024-08-21
• Status Verified: 2025-01
• Primary Completion: 2025-01-20
• Study Completion: 2025-01-20
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical (OMNI Surgical System (OSS))	OMNI Surgical System	Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.
Standard Medical Care (SMC)	Latanoprost plus adjunctive glaucoma medication	Standard Medical Care with Latanoprost and one or two adjunctive glaucoma medications at the discretion of the Principal Investigator

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Corneal or conjunctival staining	12 months	Proportion of eyes with improvement in corneal staining or conjunctival staining by at least one category with no worsening in either at 12 months compared to baseline.
Number of Ocular Hypotensive Medications	12 months	Mean number of ocular hypotensive medications used at 12 months
Diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive)	12 months	Proportion of eyes at 12 months post-randomization, with mean medicated diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive).
Tear break-up time (TBUT)	12 months	Proportion of eyes with a minimal clinically important difference (MCID) defined as a 1 category improvement, in tear beak-up time (TBUT)
OSDI score	12 months	Proportion of subjects with a MCID in ocular surface disease index (OSDI) score at 12 months compared to baseline

Trial Locations

Locations (2)

North Bay Eye Associates; 🇺🇸 Petaluma, California, United States

University Eye Specialists; 🇺🇸 Maryville, Tennessee, United States