Primary Open Angle GlaucomaNCT06991270
OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
A study testing OMNI 3.0 Surgical System in people with Primary Open Angle Glaucoma, run by Sight Sciences, Inc. at 1 site in Panama.
Trial 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 more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- OMNI 3.0 Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePanama
- Study dates
- 8 Oct 2025to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Retinal laser procedure ≤3 months prior to baseline
- Any form of glaucoma other than POAG.
- Use of topical ocular steroids.
- Clinically significant 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the OMNI 3.1 Surgical System in Subjects With Primary Open-Angle Glaucoma
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).
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- OMNI 3.0 Surgical System
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNI 3.0 Surgical SystemDevice
Canaloplasty and trabeculotomy.
| Study group | Role | What they receive |
|---|---|---|
| OMNI 3.0 | Experimental | Canaloplasty and trabeculotomy using the OMNI 3.0 surgical system, combined with phacoemulsification cataract surgery, OR as a standalone procedure in pseudophakic eyes. Receives: Device: OMNI 3.0 Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
Secondary Effectiveness Endpoint 1
Change in mean Intraocular Pressure (IOP) at 3 months post-operatively
Measured: 3 months
Secondary Effectiveness Endpoint 2
Average number of ocular hypotensive medications used at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start8 Oct 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991270
- Sponsor's protocol ID
- 09712
- Status last verified
- Oct 2026
- First submitted
- 19 May 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No