Health Trials

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

ConditionPrimary Open Angle Glaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorSight Sciences, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Laser trabeculoplasty ≤180 days prior to baseline

Durysta ≤12 months prior to baseline

Any implanted glaucoma device

Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy

Trial design

Design model

Single group

Treatments tested in this trial

  • OMNI 3.0 Surgical System

    Device

    Canaloplasty and trabeculotomy.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: OMNI 3.0Experimental treatment 1 intervention

Trial outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sight Sciences, Inc.

Lead sponsor

Source ClinicalTrials.gov
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