Open Angle GlaucomaNCT03861169

Study of OMNI System in OAG (GEMINI)

A study testing Transluminal viscoelastic delivery and trabeculotomy in people with Open Angle Glaucoma, run by Sight Sciences, Inc. at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle… Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Open Angle Glaucoma
What is being tested?: Transluminal viscoelastic delivery and trabeculotomy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 209 participants
Where: 15 sitesUnited States
Study dates: 11 Mar 2019to 4 May 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Only one eye of each subject was eligible (the "study eye"), and all ocular criteria listed below applied to the study eye.
Male or female subjects, 22 years or older
Visually significant cataract
Diagnosed with mild to moderate open-angle glaucoma (e.g., primary open-angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record per ICD-10 guidelines
At screening, a medicated IOP ≤ 33 mmHg and on 1-4 IOP-lowering medications1 with a stable medication regimen for two months prior to screening visit
At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher than screening IOP

Show all 11Show fewer

Scheduled for cataract extraction followed by ab- interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System
Shaffer grade of ≥ 3 in all four quadrants
Potential of good best corrected visual acuity post cataract extraction, in the Investigator's judgment
Able and willing to comply with the protocol, including all follow-up visits.
Understood and signed the informed consent

Who cannot join

All criteria listed below applied to the study eye; both eyes of a single subject need not have been eligible for the study.
Any of the following prior treatments for glaucoma:
Laser trabeculoplasty ≤ 3 months prior to baseline
Implanted with iStent, CyPass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
Normal tension glaucoma

Show all 13Show fewer

Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Severe glaucoma as documented in subjects' medical record per ICD-10 guidelines
Use of oral hypotensive medication treatment for glaucoma
In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
Ocular pathology or 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, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits)
Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator
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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Omni Eye Services
Atlanta, Georgia, 30342
Vance Thompson Vision - MT
Bozeman, Montana, 59718
Eye Center South
Dothan, Alabama, 36301
El Paso Eye Surgeons
El Paso, Texas, 79902
Vold Vision
Fayetteville, Arkansas, 72704
Ophthalmology Associates
Fort Worth, Texas, 76102
Eye Physicians and Surgeons, LLP
Iowa City, Iowa, 52245
Northern Ophthalmics
Jenkintown, Pennsylvania, 19406
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, 53142
Barnet Delaney Perkins Eye Center
Lake Havasu City, Arizona, 86403
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, 73104
Vance Thompson Vision - NE
Omaha, Nebraska, 68154
Vance Thompson Vision - ND
West Fargo, North Dakota, 58708
Your Eye Specialists
Weston, Florida, 33326
Grene Vision Group
Wichita, Kansas, 62708

Other trials in United States

About this study

Official title: Prospective, Multi-Center, Single-Arm Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma

Read the detailed description

This prospective, multicenter, single-arm, post-market clinical study will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive medications in patients with mild to moderate open angle glaucoma.

Conditions: Open Angle Glaucoma
Being tested: Transluminal viscoelastic delivery and trabeculotomy
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.

Transluminal viscoelastic delivery and trabeculotomyDevice
Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System

Study groups in NCT03861169
Study group	Role	What they receive
Viscoeleastic delivery & trabeculotomy	Experimental	Patients with open angle glaucoma and cataract Receives: Device: Transluminal viscoelastic delivery and trabeculotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Unmedicated Diurnal IOP
Change in mean unmedicated diurnal IOP from baseline to 12 months
Measured: 12 months
Change in Mean Number of IOP-Lowering Medications
Reduction in mean number of IOP-lowering medications from screening to 12 months
Measured: 12 months

Secondary outcomes (2)

Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP
First Secondary Effectiveness endpoint/Percent of eyes with a ≥20% reduction in unmedicated DIOP at 12 months
Measured: 12 months
Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months
Second Secondary Effectiveness Endpoint: Unmedicated DIOP ≥ 6 mmHg and ≤ 18 mmHg at 12 Months/Percent of eyes with unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Mar 20194 May 2021

First posted4 Mar 2019
Study start11 Mar 2019
Primary completion4 May 2021
Study completion4 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03861169
Sponsor's protocol ID: 06213
Status last verified: Jul 2024
First submitted: 25 Feb 2019
Last updated: 14 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multi-Center, Single-Arm Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
ClinicalTrials.gov ID: NCT03861169
Acronym / sponsor ID: 06213
Conditions: Open Angle Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: Sight Sciences, Inc.Industry (pharma, biotech, devices)
Study start: 11 Mar 2019 (actual)
Primary completion: 4 May 2021 (actual)
Study completion: 4 May 2021 (actual)
First posted: 4 Mar 2019 (actual)
Results: Posted 14 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Viscoeleastic delivery & trabeculotomy	Experimental	Device: Transluminal viscoelastic delivery and trabeculotomyPatients with open angle glaucoma and cataract

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Only one eye of each subject was eligible (the "study eye"), and all ocular criteria listed below applied to the study eye.
Male or female subjects, 22 years or older
Visually significant cataract
Diagnosed with mild to moderate open-angle glaucoma (e.g., primary open-angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record per ICD-10 guidelines
At screening, a medicated IOP ≤ 33 mmHg and on 1-4 IOP-lowering medications1 with a stable medication regimen for two months prior to screening visit

Key exclusion criteria (13 listed)

All criteria listed below applied to the study eye; both eyes of a single subject need not have been eligible for the study.
Any of the following prior treatments for glaucoma:
Normal tension glaucoma
Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Severe glaucoma as documented in subjects' medical record per ICD-10 guidelines

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transluminal viscoelastic delivery and trabeculotomyAb-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System	Device	Viscoeleastic delivery & trabeculotomy

Primary outcome

Change in Mean Unmedicated Diurnal IOP
Time frame: 12 months
Change in mean unmedicated diurnal IOP from baseline to 12 months
Change in Mean Number of IOP-Lowering Medications
Time frame: 12 months
Reduction in mean number of IOP-lowering medications from screening to 12 months

2 secondary outcomes

Percent of Eyes With a ≥20% Reduction in Unmedicated DIOP
Time frame: 12 months
Percent of Eyes With Unmedicated Diurnal IOP Between 6 and 18 mmHg Inclusive at 12 Months
Time frame: 12 months

Results and safety

Results posted to the registry on 14 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OMNI® Surgical System	209	149

Primary outcome: Change in Mean Unmedicated Diurnal IOP

Time frame: 12 months. Mean (Standard Deviation). Unit: mm Hg

Measure	Per Protocol Population n = 120
Value	7.98 (4.21)

Population analysed: The Per Protocol (PP) analysis population was a subset of the mITT population and included all subjects who were on least one ocular hypotensive medication at screening and had uneventful cataract extraction followed by ab-interno transluminal viscoelastic delivery and trabeculotomy, 12 month IOP and medication data, and had no clinically significant protocol deviations.

Primary outcome: Change in Mean Number of IOP-Lowering Medications

Time frame: 12 months. Mean (Standard Deviation). Unit: medications

Measure	Per Protocol Population n = 120
Value	1.43 (1.14)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
iTT/Safety	2 of 149 (1.3%)	34 of 149 (22.8%)	34 of 149

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Open Angle Glaucoma

RecruitingPhase 2
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Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
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RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
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RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jaime Dickerson, PhD study director

Sight Sciences

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transluminal viscoelastic delivery and trabeculotomy in people with Open Angle Glaucoma, run by Sight Sciences, Inc. at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Unmedicated Diurnal IOP (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03861169.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.