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

Stopped early · Phase 4

Conditions studied: Primary Open Angle Glaucoma

In brief

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)

Key facts

Study ID: NCT06407973
Run by: Sight Sciences, Inc.
People needed: 2
Starts: 2024-08-21
Expected to finish: 2025-01-20
Last updated by the study team: 2025-01-29

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

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
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
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

Where it is running

North Bay Eye Associates — Petaluma, California, United States
University Eye Specialists — Maryville, Tennessee, United States

Full record on ClinicalTrials.gov

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