TerminatedNCT04658095Updated Oct 27, 2025Results posted

Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)

An interventional study of Canaloplasty and trabeculotomy with the OMNI system. and iStent inject in Glaucoma, Open-Angle, sponsored by Sight Sciences, Inc.. Terminated at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-27.

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

Why this study was terminated

Business Decision

Phase: Not applicable
Study type: Interventional
Enrollment: 10
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.

Read the detailed description

A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.

Conditions studied

Glaucoma, Open-Angle

Browse trials for

Glaucoma, Open-Angle 929

In context

Glaucoma, Open-Angle

929 studies on the registry are indexed under Glaucoma, Open-Angle; 122 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 700 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

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.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female subjects, 18 years or older
Pseudophakic
Diagnosis of open angle glaucoma (OAG)
On 1-5 ocular hypotensive medications

Exclusion criteria

Exclusion Criteria:

Any of the following prior treatments for glaucoma:
- Suprachoroidal stent (e.g. Cypass, iStent Supra)
- Laser trabeculoplasty ≤ 8 weeks prior to Baseline visit with a MIGS or other glaucoma device including but not limited to iStent, iStent inject, Hydrus, CyPass
- Trabeculectomy or other bleb forming procedure including Xen, PreserFlo, Express, glaucoma draining device/valve
- Prior canaloplasty, goniotomy, or trabeculotomy including procedures with GATT, Kahook Dual Blade, iTrack, Trabectome
- Ciliary ablation procedures including Endocyclophotocoagulation (ECP), Cyclophotocoagulation (G probe), Micropulse laser, or high intensity focused ultrasound (HIFU)
Any other form of glaucoma other than OAG
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 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).
Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Active comparator
Ab-interno canaloplasty and trabeculotomy using the OMNI Surgical System
Sequential canaloplasty (up to 360 degrees) and trabeculotomy (up to 360 degrees)
Device: Canaloplasty and trabeculotomy with the OMNI system.
Active comparator
Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System
Canaloplasty alone (up to 360 degrees)
Device: Canaloplasty
Active comparator
Ab-interno implantation of iStent inject (2 microstents)
Implantation of trabecular micro bypass stents as per manufacturer's instructions.
Device: iStent inject

Interventions

DeviceCanaloplasty and trabeculotomy with the OMNI system.
Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy
DeviceiStent inject
Ab-interno implantation of iStent inject (2 microstents)
DeviceCanaloplasty
Ab-interno canaloplasty (360 degrees) using the OMNI

What researchers measure

Primary outcomes

Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.
Time frame: 12 months

Results

Posted Oct 27, 2025

Participant flow

Participant flow — Overall Study
Milestone	Canaloplasty Only With the OMNI Surgical System	Canaloplasty + Trabeculotomy With the OMNI Surgical System	iStent Inject
Started	5	1	4
Completed	0	0	0
Not completed	5	1	4
Withdrew: Study terminated	5	1	4

Outcome measures

PrimaryMean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination

Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.

Time frame:: 12 months

No measurements were reported for this outcome.

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
OMNI-canaloplasty Alone	0/5 (0%)	0/5 (0%)	3/5 (60%)
OMNI-canaloplasty + Trabeculotomy	0/1 (0%)	0/1 (0%)	1/1 (100%)
iStent Inject	0/4 (0%)	0/4 (0%)	0/4 (0%)

Most frequent other events

Most frequent other events
Event	OMNI-canaloplasty Alone	OMNI-canaloplasty + Trabeculotomy	iStent Inject
COVID-19 infectionRespiratory, thoracic and mediastinal disorders	1/5	1/1	0/4
IOP elevationEye disorders	2/5	0/1	0/4
Anterior chamber inflammationEye disorders	1/5	0/1	0/4
Allergic conjunctivitisEye disorders	1/5	0/1	0/4
TendinitisGeneral disorders	1/5	0/1	0/4

Baseline characteristics

The safety analysis population will contain all subjects for whom either the OMNI (canaloplasty alone), OMNI (canaloplasty AND trabeculotomy), or iStent inject is attempted. The study was terminated early due to a business decision.

Age, Continuous
Age, Continuous(years)	OMNI-Canaloplasty Only	OMNI-canaloplasty + Trabeculotomy	iStent Inject	Total
Mean	75.6 ± 3.5	71 ± 0	74.5 ± 5.1	74.7 ± 4.0

Sex: Female, Male
Sex: Female, Male(Participants)	OMNI-Canaloplasty Only	OMNI-canaloplasty + Trabeculotomy	iStent Inject	Total
Female	2	0	3	5
Male	3	1	1	5

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	OMNI-Canaloplasty Only	OMNI-canaloplasty + Trabeculotomy	iStent Inject	Total
Hispanic or Latino	2	0	1	3
Not Hispanic or Latino	2	1	3	6
Unknown or Not Reported	1	0	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	OMNI-Canaloplasty Only	OMNI-canaloplasty + Trabeculotomy	iStent Inject	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	1	1
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	0	0
White	5	1	3	9
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	OMNI-Canaloplasty Only	OMNI-canaloplasty + Trabeculotomy	iStent Inject	Total
United Kingdom	1	0	1	2
Spain	4	1	2	7
Poland	0	0	1	1

Diurnal IOP (DIOP)
Diurnal IOP (DIOP)(mm Hg)	OMNI-Canaloplasty Only	OMNI-canaloplasty + Trabeculotomy	iStent Inject	Total
Mean	29.0 ± 4.4	26 ± 0	24.3 ± 0.5	26.8 ± 3.8

Study locations

5 sites

BurgerHospital
Frankfurt, Germany
Institut Catala de Retina (ICR)
Barcelona, 08022, Spain
Universidad Complutense de Madrid
Valencia, 46026, Spain
Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle
Zaragoza, 50009, Spain
Manchester Royal Eye Hospital
Manchester, M13, United Kingdom

References and documents

Study documents

Protocol and statistical analysis plan · Sep 14, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04658095
Lead sponsor: Sight Sciences, Inc.
Responsible party: Sponsor
First posted: Dec 8, 2020
Start date: Jan 11, 2022
Primary completion: Nov 18, 2022
Completion: Nov 18, 2022
Results posted: Oct 27, 2025
Last update: Oct 27, 2025

Study contacts

Jaime Dickerson, PhD

study director · Sight Sciences, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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