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Active, not recruitingNCT06991270Updated Oct 19, 2026

OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma

An interventional study of OMNI 3.0 Surgical System in Primary Open Angle Glaucoma, sponsored by Sight Sciences, Inc.. Active, not recruiting at 1 site in Panama. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Sight Sciences, Inc. · Not applicable, Interventional, and Treatment

Updated Oct 19, 2026Now Active, not recruitingStart date moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
45 Years and older
Sex
All
01

Study summary

To gain early evidence of safety and assess the effectiveness of the intraocular pressure (IOP)-lowering effectiveness of the OMNI 3.0 Surgical System in primary open-angel glaucoma (POAG).

Read the detailed description

To assess the safety of the OMNI 3.0 Surgical System and gain early evidence on intraocular pressure (IOP) -lowering effectiveness in subjects with mild-moderate primary open-angle glaucoma (POAG).

02

Conditions studied

  • Primary Open Angle Glaucoma

Browse trials for

03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 25 is below the median of 80 across 692 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Sight Sciences, Inc. is the lead sponsor of 17 studies on the registry; none are 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.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female subjects, 45 years or older
  • Visually significant age-related cataract and requiring phacoemulsification cataract surgery, OR, pseudophakic and a minimum of six months since cataract surgery.
  • Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months.
  • Diagnosed with mild to moderate primary open angle glaucoma (POAG). Diagnosis must include evidence of glaucomatous optic nerve damage or visual field defect consistent with glaucomatous optic nerve damage

Exclusion criteria

Exclusion Criteria:

  • Any of the following prior ocular procedures:

    • Laser trabeculoplasty ≤180 days prior to baseline
    • Durysta ≤12 months prior to baseline
    • Any implanted glaucoma device
    • Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy
    • Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU), ≤180 days prior to baseline
    • Retinal laser procedure ≤3 months prior to baseline
  • Any form of glaucoma other than POAG.
  • Use of topical ocular .
  • concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet age-related macular degeneration (AMD), corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits). Dry AMD and Non- proliferative diabetic retinopathy are not excluded.
  • History of penetrating keratoplasty or another corneal transplant; corneal abnormality that would prevent reliable IOP measurement, e.g. keratoconus or abnormally thick (≥ 620 µM) or thin (≤ 480 µM) cornea.
  • Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure.
  • BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract.
  • BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    OMNI 3.0

    Canaloplasty and trabeculotomy using the OMNI 3.0 surgical system, combined with phacoemulsification cataract surgery, OR as a standalone procedure in pseudophakic eyes.

    Device: OMNI 3.0 Surgical System

Interventions

  • DeviceOMNI 3.0 Surgical System

    Canaloplasty and trabeculotomy.

06

What researchers measure

Primary outcomes

  1. Primary Effectiveness Endpoint

    Proportion of subjects with a ≥ 20% reduction from baseline in mean IOP at the 3-month post-operative endpoint and on the same or fewer medications as preoperatively.

    Time frame: 3 months

Secondary outcomes

  1. Secondary Effectiveness Endpoint 1

    Change in mean Intraocular Pressure (IOP) at 3 months post-operatively

    Time frame: 3 months

  2. Secondary Effectiveness Endpoint 2

    Average number of ocular hypotensive medications used at 3 months

    Time frame: 3 months

Other outcomes

  1. Safety Endpoint

    Rate of perioperative and postoperative ocular adverse events (AEs)

    Time frame: 3 months

  2. Safety Endpoint

    Best Corrected Visual Acuities (BCVA) (% of eyes that lose 2 lines or more (10 ETDRS letters) at Month 3

    Time frame: 3 months

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Dec 2026, 13 months after the start.

Of 70 industry-sponsored interventional studies with no phase under Glaucoma, Open-Angle, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 64. This study's planned 13 months is below that.

Counting every sponsor, half of 170 studies reached it within 35 months; a quarter within 19 and three quarters within 61.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: start Feb 2026 → Oct 2025, primary completion Aug 2026 → Dec 2026 and completion May 2027 → Aug 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 19, 2025
First posted
May 27, 2025
StartActual
Oct 8, 2025was Feb 2026
Primary completionEst.
Dec 1, 2026was Aug 2026
CompletionEst.
Aug 31, 2027was May 2027
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 19, 2026
Start date
Feb 2026→Oct 8, 2025 (actual)
Oct 19, 2026
Primary completion
Aug 31, 2026→Dec 1, 2026
Oct 19, 2026
Study completion
May 2027→Aug 31, 2027
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Recruiting→Active, not recruiting
    Start date Feb 2026→Oct 8, 2025 (now actual)
    Primary completion Aug 31, 2026→Dec 1, 2026
    Study completion May 2027→Aug 31, 2027
    + 4 other changes: verification date, oversight details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06991270
Lead sponsor
Sight Sciences, Inc.
Responsible party
Sponsor
First posted
May 27, 2025
Start date
Oct 8, 2025
Primary completion
Dec 1, 2026 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Oct 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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