Glaucoma, Open-AngleNCT04616573
A Post-market Study Of Use Of The OMNI® Surgical System In Open Angle Glaucoma
A study testing OMNI® Surgical System and iStent inject in people with Glaucoma, Open-Angle, run by Sight Sciences, Inc. at 2 sites in United States.
Trial summary
To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma. 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 and iStent inject
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2020to 20 Jan 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
- Visually significant cataract
- Mild to moderate open angle glaucoma
- On 1-5 IOP-lowering medications
- 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.
- Understand and sign the informed consent.
Who cannot join
- Any of the following prior treatments for glaucoma:
- Laser trabeculoplasty ≤3 months prior to baseline
- Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
- Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
- Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record.
- 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).
- 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
2 sites in 1 country.
United States2 sites
Eye Center South
Dothan, Alabama, 36301
Eye Associates and SurgiCenter of Vineland
Vineland, New Jersey, 08361
About this study
Official title: A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)
To prospectively compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.
Read the detailed description
First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)
- Conditions
- Glaucoma, Open-Angle
- Being tested
- OMNI® Surgical System, iStent inject
- 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
iStent injectDevice
Trabecular meshwork implantation
| Study group | Role | What they receive |
|---|---|---|
| Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System | Active comparator | Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System Receives: Device: OMNI® Surgical System |
| Ab-interno transluminal viscoelastic delivery using OMNI surgical System | Active comparator | Ab-interno transluminal viscoelastic delivery using OMNI surgical System Receives: Device: OMNI® Surgical System |
| iStent Inject implantation | Active comparator | iStent Inject implantation using the iStent device Receives: Device: iStent inject |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Unmedicated Diurnal Intraocular Pressure (DIOP)
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Measured: 1 week
Secondary outcomes (4)
Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Measured: 1 week
Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Measured: 1 week
Change in the Number of Ocular Hypotensive Medications Compared to Screening
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Measured: 1 week
Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start13 Nov 2020
- Primary completion20 Jan 2021
- Study completion20 Jan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sight Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kavita Dhamdhere, MD, PhD, Study chair, Sight Sciences, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616573
- Sponsor's protocol ID
- 07024
- Status last verified
- Nov 2022
- First submitted
- 30 Oct 2020
- Last updated
- 1 Dec 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 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)
- ClinicalTrials.gov ID
- NCT04616573
- Acronym / sponsor ID
- 07024
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Sight Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Posted 1 Dec 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 compare the clinical effect of the OMNI surgical system in eyes with Open Angle Glaucoma.
Detailed description
First, to prospectively compare the clinical effect of the transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG) and second, to prospectively compare the clinical effect of the transluminal viscoelastic delivery using the OMNI Surgical System to the iStent Inject used with Cataract Extraction in eyes with open angle glaucoma (OAG)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System | Active comparator | Device: OMNI® Surgical SystemAb-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System |
| Ab-interno transluminal viscoelastic delivery using OMNI surgical System | Active comparator | Device: OMNI® Surgical SystemAb-interno transluminal viscoelastic delivery using OMNI surgical System |
| iStent Inject implantation | Active comparator | Device: iStent injectiStent Inject implantation using the iStent device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, 22 years or older
- Visually significant cataract
- Mild to moderate open angle glaucoma
- On 1-5 IOP-lowering medications
- Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment
Key exclusion criteria (8 listed)
- Any of the following prior treatments for glaucoma:
- Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, neovascular or severe glaucoma as documented in subjects' medical record.
- 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).
- 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.
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 | Ab-interno transluminal viscoelastic delivery using OMNI surgical System, Ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI surgical System |
| iStent injectTrabecular meshwork implantation | Device | iStent Inject implantation |
Primary outcome
Change in Unmedicated Diurnal Intraocular Pressure (DIOP)
Time frame: 1 week
The trial was terminated early after randomization and treatment of one subject who was exited from the study after 1 week of follow up. No meaningful conclusions or results were obtained due to early termination after the treatment of one subject.
4 secondary outcomes
Eyes With a ≥ 20% Decrease in Unmedicated Mean Diurnal Intraocular Pressure (DIOP) From Baseline
Time frame: 1 week
Eyes With Unmedicated Diurnal Intraocular Pressure (DIOP) Between 6 and 18 mmHg Inclusive
Time frame: 1 week
Change in the Number of Ocular Hypotensive Medications Compared to Screening
Time frame: 1 week
Change in Unmedicated Diurnal Intraocular Pressure (DIOP) From Baseline
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 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.
Kavita Dhamdhere, MD, PhD study chair
Sight Sciences, Inc.
2 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 and iStent inject in people with Glaucoma, Open-Angle, run by Sight Sciences, Inc. at 2 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 7 inclusion and 8 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 Dec 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 Unmedicated Diurnal Intraocular Pressure (DIOP) (time frame: 1 week). 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 1 Dec 2022.