A Clinical Trial Comparing the OMNI Surgical System to Standard Medical Treatment in Pseudophakic Eyes

Primary Open Angle Glaucoma Clinical Trial

— EVOLVE  

Official title:

A Randomized Clinical Trial of ab Interno Canaloplasty and Trabeculotomy With the OMNI Surgical System Compared to Standard Medical Treatment in Pseudophakic Patients With Primary Open Angle Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06407973
• Other study ID #: 09074
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 30, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: May 2024
• Source: Sight Sciences, Inc.
• Contact: Jaime Dickerson, PhD
• Phone: +1 (817) 845-0859
• Email: jdickerson[@]sightsciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This prospective, multicenter, post-market clinical trial will evaluate the safety and effectiveness of canaloplasty and trabeculotomy using the OSS in pseudophakic patients with POAG with DIOP ≥ 20 mmHg on prostaglandin monotherapy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 334
• Est. completion date: May 31, 2027
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

3. Under treatment with a topical prostaglandin F2 analog (e.g. latanoprost, travoprost, bimatoprost, tafluprost) as monotherapy for a minimum of 3 months prior to the Screening visit.

4. Intraocular pressure (IOP) at the Screening visit of 20 mmHg or more 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

• Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device; or

• Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, endoscopiccyclophotocoagulation (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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

Intervention

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. An adjunctive topical glaucoma medication of a different class as selected by the Investigator

Locations

Country	Name	City	State
United States	University Eye Specialists	Maryville	Tennessee
United States	North Bay Eye Associates	Petaluma	California

Sponsors (1)

Lead Sponsor	Collaborator
Sight Sciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Ocular Hypotensive Medications	Mean number of ocular hypotensive medications used at 12 months	12 months
Secondary	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
Secondary	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
Secondary	OSDI score	Proportion of subjects with a MCID in ocular surface disease index (OSDI) score at 12 months compared to baseline	12 months