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

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

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)

Study Overview

• Status: Terminated
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Device: OMNI Surgical System; Drug: Latanoprost plus adjunctive glaucoma medication

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates
  • Tennessee
    • Maryville, Tennessee, United States, 37803
      • University Eye Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgical (OMNI Surgical System (OSS)); Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.	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; Other Names: OMNI
Active Comparator: Standard Medical Care (SMC); 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive)	Proportion of eyes at 12 months post-randomization, with mean medicated diurnal IOP (DIOP) between 6 and 18 mmHg (inclusive).	12 months
Number of Ocular Hypotensive Medications	Mean number of ocular hypotensive medications used at 12 months	12 months
Tear break-up time (TBUT)	Proportion of eyes with a minimal clinically important difference (MCID) defined as a 1 category improvement, in tear beak-up time (TBUT)	12 months
Corneal or conjunctival staining	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.	12 months
OSDI score	Proportion of subjects with a MCID in ocular surface disease index (OSDI) score at 12 months compared to baseline	12 months

Collaborators and Investigators

• Sponsor: Sight Sciences, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): January 20, 2025
• Study Completion (Actual): January 20, 2025

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Ophthalmic Solutions; Pharmaceutical Solutions; Latanoprost
• Other Study ID Numbers: 09074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No