Glaucoma, Open-AngleORIONNCT04465630
A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma
A study testing OMNI® Surgical System in people with Glaucoma, Open-Angle, run by Sight Sciences, Inc. at 11 sites in United States.
Trial summary
To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma (OAG). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- OMNI® Surgical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 11 sitesUnited States
- Study dates
- 19 Jun 2020to 2 Mar 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
- Male or female subjects, 22 years or older at the time of surgery
- History of uncomplicated cataract surgery and posterior chamber IOL implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit.
- Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record substantiated using funduscopic exam or OCT and at least one visual field test with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.
- Mean deviation score must be better than or equal to -12.0 dB
- The visual field test may be historical (within 6 months prior to Screening Visit). If needed, visual field testing may be repeated between the Screening Visit and the Surgery Visit.
- At the Screening visit, IOP of ≤ 36 mmHg while on 1-5 ocular hypotensive medications1 with a stable medication regimen for at least 2 months.
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- At Baseline visit, unmedicated diurnal i) IOP ≥ 22.5 and ≤ 39mmHg and ii) IOP at least 3 mmHg higher than screening IOP and iii) IOP at 7:30AM ≥ 24
- Scheduled for ab-interno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System.
- Shaffer grade of ≥ III in all four quadrants
- Able and willing to comply with the protocol, including all follow-up visits.
- Understands and signs the informed consent
Who cannot join
- Any of the following prior treatments for glaucoma:
- Laser trabeculoplasty ≤3 months prior to Baseline visit
- iStent or iStent Inject implanted ≤6 months prior to Baseline visit
- Endocyclophotocoagulation (ECP) or Micropulse laser ≤ 6 months prior to Baseline visit
- Trabeculectomy or other bleb forming procedure including Xen, Express, glaucoma draining device/valve
- Prior canaloplasty, goniotomy, or trabeculotomy
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- Hydrus microstent
- Suprachoroidal stent (e.g. Cypass, iStent Supra)
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Concurrent IOP-lowering procedure other than use of the OMNI Surgical System at the time of surgery (e.g. ECP, CPC, etc.)
- In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
- 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).
- History of penetrating keratoplasty or another corneal transplant
- BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to cataract
- Study of OMNI System in POAG
- BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to posterior capsular opacification (uneventful Nd:YAG laser capsulotomy 6 months prior to baseline is permitted only if there is no vitreous present in or in front of the iris plane at the time of baseline).
- 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Minnesota Eye Consultants
Bloomington, Minnesota, 55431
El Paso Eye Surgeons
El Paso, Texas, 79902
Vold Vision
Fayetteville, Arkansas, 72704
Ophthalmology Associates - Fort Worth
Fort Worth, Texas, 76102
University Eye Specialists
Maryville, Tennessee, 37803
Visionary Eye Institute
Newport Beach, California, 92663
Utah Eye Centers
Ogden, Utah, 84403
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, 73112
North Bay Eye Associates
Petaluma, California, 94954
Assil Eye Institute
Santa Monica, California, 90404
Grene Vision Group
Wichita, Kansas, 62708
About this study
To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma (OAG).
- Conditions
- Glaucoma, Open-Angle
- Being tested
- OMNI® 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® Surgical SystemDevice
Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
| Study group | Role | What they receive |
|---|---|---|
| Pseudophakic eyes with Open Angle Glaucoma | Other | Eligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. Receives: Device: OMNI® Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP)
Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure
Measured: 6 months
Secondary outcomes (1)
Change in Number of Medications
Change in the number of ocular hypotensive medications between screening and 6 months for subjects who reached the 6-month post-operative timepoint by the time of study closure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start19 Jun 2020
- Primary completion2 Mar 2021
- Study completion2 Mar 2021
Why it stopped: Sponsor Decision
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 Glaucoma, Open-AngleStudies 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465630
- Sponsor's protocol ID
- 06807
- Acronym
- ORION
- Status last verified
- May 2022
- First submitted
- 7 Jul 2020
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT04465630
- Acronym / sponsor ID
- ORION / 06807
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 2 Mar 2021 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Posted 7 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System in pseudophakic eyes on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with open angle glaucoma (OAG).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pseudophakic eyes with Open Angle Glaucoma | Other | Device: OMNI® Surgical SystemEligible subjects enrolled in the trial will receive surgery for Open Angle Glaucoma using the OMNI® Surgical System. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects, 22 years or older at the time of surgery
- History of uncomplicated cataract surgery and posterior chamber IOL implantation without compromise to the lens capsule, zonular dehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit.
- Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in subjects' medical record substantiated using funduscopic exam or OCT and at least one visual field test with the Humphrey automated perimeter using the SITA Standard 24-2 testing algorithm.
- At the Screening visit, IOP of ≤ 36 mmHg while on 1-5 ocular hypotensive medications1 with a stable medication regimen for at least 2 months.
- At Baseline visit, unmedicated diurnal i) IOP ≥ 22.5 and ≤ 39mmHg and ii) IOP at least 3 mmHg higher than screening IOP and iii) IOP at 7:30AM ≥ 24
Key exclusion criteria (18 listed)
- Any of the following prior treatments for glaucoma:
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Concurrent IOP-lowering procedure other than use of the OMNI Surgical System at the time of surgery (e.g. ECP, CPC, etc.)
- In the Investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications
- 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).
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 |
|---|---|---|
| OMNI® Surgical SystemAb-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System | Device | Pseudophakic eyes with Open Angle Glaucoma |
Primary outcome
Change in Intraocular Pressure (IOP)
Time frame: 6 months
Change in unmedicated mean diurnal IOP (DIOP) for subjects who reached the 6-month post-operative timepoint by the time of study closure
1 secondary outcome
Change in Number of Medications
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNI® Surgical System in people with Glaucoma, Open-Angle, run by Sight Sciences, Inc. at 11 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 18 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: stopped early, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 7 Jun 2022). 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 Intraocular Pressure (IOP) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2022.