NCT05044793

A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System

Completed Results posted Last updated 22 January 2025

What this trial tests

trial testing OMNI® Surgical System in Glaucoma, Open-Angle in 70 participants. Completed in 21 August 2023.

Timeline

1 September 2021

Primary endpoint
21 August 2023

21 August 2023

Quick facts

Lead sponsor	Sight Sciences, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	70
Start date	1 September 2021
Primary completion	21 August 2023
Estimated completion	21 August 2023
Sites	4 locations across United States

Drugs / interventions tested

• OMNI® Surgical System

Conditions studied

• Glaucoma, Open-Angle — all drugs for Glaucoma, Open-Angle →

Sponsor

Sight Sciences, Inc. — full company profile →

Who can join

Eligibility, any sex, with Glaucoma, Open-Angle. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Safety Endpoint Primary · 12 months

Rate of occurrence of sight-threatening adverse events

Group	Value	95% CI
Cohort A	0	± 0
Cohort B	0	± 0

Change in Intraocular Pressure (IOP) Secondary · 12 months

Mean change in IOP

Group	Value	95% CI
Cohort A	-6.89	± 3.42
Cohort B	-11.00	± 16.45

Change in Hypotensive Medications Secondary · 12 months

Reduction in number of hypotensive medications from baseline to 36 months

Group	Value	95% CI
Cohort A	-1.2	± 0.87
Cohort B	-1.0	± 1.00

Number of Participants With ≥20% Reduction in IOP From Baseline to 36 Months Secondary · 12 months

For subjects in cohort A : ≥20% reduction in unmedicated diurnal IOP from baseline to 36 months For subjects in cohort B: ≥20% reduction in mean medicated IOP from baseline to 36 months

Group	Value	95% CI
Cohort A	45
Cohort B	1

Number of Participants With Intraocular Pressure (IOP) Between 6 and 18mmHg Inclusive. Secondary · 12 months

For cohort A: unmedicated diurnal IOP between 6 and 18 mmHg inclusive For cohort B: medicated IOP between 6 and 18 mmHg inclusive

Group	Value	95% CI
Cohort A	41
Cohort B	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 36 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A

Serious: 1/66 (2%)

Deaths: 0/66

Cohort B

Serious: 0/4 (0%)

Deaths: 0/4

Serious adverse events (1 terms)

Reaction	System	Cohort A	Cohort B
Adverse events	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Cohort A	Cohort B
Ocular adverse events	Eye disorders	—	—

Most-reported serious reactions: Adverse events.

Data from ClinicalTrials.gov NCT05044793 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® Surgical System in subjects who were treated under protocol #06213

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 36-Month Outcomes from the Prospective GEMINI Study: Canaloplasty and Trabeculotomy Combined with Cataract Surgery for Patients with Primary Open-Angle Glaucoma.
   Greenwood MD, Yadgarov A, Flowers BE, Sarkisian SR, et al · · 2023 · cited 9× · PMID 38105915 · DOI 10.2147/opth.s446486
2. Emerging glaucoma treatments: are we seeing an improvement in adherence?
   Droste AP, Newman-Casey PA. · · 2023 · cited 6× · PMID 37520660 · DOI 10.1080/17469899.2023.2199981