A Phase 4 interventional study of OMNI Surgical System and Latanoprost plus adjunctive glaucoma medication in Primary Open Angle Glaucoma, sponsored by Sight Sciences, Inc.. Terminated at 2 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Sight Sciences, Inc. · Phase 4, Interventional, and Treatment
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)
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 2 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Sight Sciences, Inc. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Any of the following prior ocular procedures:
Canaloplasty followed by Trabeculotomy using the OMNI Surgical System.
Device: OMNI Surgical System
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
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
* 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
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
Time frame: 12 months
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).
Time frame: 12 months
Number of Ocular Hypotensive Medications
Mean number of ocular hypotensive medications used at 12 months
Time frame: 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)
Time frame: 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.
Time frame: 12 months
OSDI score
Proportion of subjects with a MCID in ocular surface disease index (OSDI) score at 12 months compared to baseline
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Sight Sciences, Inc.