Dry Eye SyndromesOMNSNCT04143841
Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
A study testing Viveye OMNS treatment in people with Dry Eye Syndromes and ATD, run by Epitech Mag Ltd. at 3 sites in Israel.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of Viveye OMNS non-invasive treatment for management of the signs and symptoms of severe dry eye disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye Syndromes, ATD, Sjogren's Syndrome
- What is being tested?
- Viveye OMNS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesIsrael
- Study dates
- 30 Oct 2019to 6 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 18-80 years old
- Subjects with severe aqueous deficient dry eye disease (concomitant meibomian gland disease is permitted):
- SPEED questionnaire score ≥ 10 AND
- Fluorescein Corneal Staining Score (FCSS) ≥ 5 NEI score in at least in one eye AND
- Schirmer score ≤ 10 mm in at least one eye (at screening or treatment day pre-treatment)
- No contact lens wear for at least seven days prior to the Screening Visit and willingness to forego contact lens wear for the duration of the study;
- Literacy, able to speak English or Hebrew, and able to complete questionnaires independently;
- Willing and able to sign the informed consent form and deemed capable of complying with the requirements of the study protocol (tests and follow-up visits).
Who cannot join
- Significant anterior blepharitis including signs of Demodex eyelid infection;
- If the subject is using prescription dry eye ophthalmic drug such as Restasis (Cyclosporine A 0.05% ophthalmic emulsion), Xiidra (Lifitegrast), Cequa (Cyclosporine 0.09% ophthalmic solution), and the medication has not been used regularly for the past 3 months prior to screening visit;
- Change in eye lubricant type usage in the last 1 month prior enrollment. Use of any device to manage DED within 1 month of Screening Visit;
- Punctal plugs are present at screening that were inserted in the last 30 days prior enrollment, or intracanalicular plug that were inserted in the last 6 months in any eyelid;
- Corneal transplant in either or both eyes;
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
E.Wolfson MC
Holon, 5822012
SZMC
Jerusalem, 9103102
Sourasky Medical Center
Tel Aviv, 6423906
About this study
Official title: A Pilot Study to Evaluate the Safety and Effectiveness of the Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
The objective of this study is to evaluate the safety and effectiveness of Viveye OMNS non-invasive treatment for management of the signs and symptoms of severe dry eye disease.
- Conditions
- Dry Eye Syndromes, ATD, Sjogren's Syndrome
- Being tested
- Viveye OMNS treatment, Viveye OMNS sham treatment
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viveye OMNS treatmentDevice
The Viveye OMNS treatment ( ~30 min) will be applied once, during the treatment visit only
Viveye OMNS sham treatmentDevice
The Viveye OMNS sham treatment ( ~30 min) will be applied once, during the treatment visit only
| Study group | Role | What they receive |
|---|---|---|
| Single treatment | Active comparator | A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye. Receives: Device: Viveye OMNS treatment |
| Single sham treatment | Sham comparator | A single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye. Receives: Device: Viveye OMNS sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity (BCVA)
Frequency of treatment related deterioration in BCVA
Measured: 12 weeks
Intraocular Pressure (IOP)
IOP results will be summarized descriptively. 95% confidence intervals for the difference between treatment arms at each visit will be presented, assuming t-distribution.
Measured: 12 weeks
Slit lamp biomicroscopy
The percent related to worsening in ocular pathological changes observed
Measured: 12 weeks
Rate of device/treatment related adverse events
Rate of device/treatment related Incidence of Adverse events (AE) will be presented in tabular form by seriousness, severity and relation to treatment
Measured: 12 weeks
Fluorescein corneal staining
Change from baseline in fluorescein corneal staining score (NEI Scale 0-15) per treatment arm and visit (lower scores mean a better outcome.)
Measured: 12 weeks
Ocular discomfort questionnaires
Change from baseline in ocular discomfort questionnaires (Standard Patient Evaluation of Eye Dryness - SPEED) per treatment arm and visit. score from 0 to 28, higher scores mean a worse outcome. (Reduction in SUM score = improvement)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start30 Oct 2019
- Primary completion6 Jan 2021
- Study completion6 Jan 2021
Why it stopped: Financial constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epitech Mag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143841
- Sponsor's protocol ID
- CLP-10003
- Acronym
- OMNS
- Status last verified
- Apr 2021
- First submitted
- 24 Sep 2019
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety and Effectiveness of the Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease
- ClinicalTrials.gov ID
- NCT04143841
- Acronym / sponsor ID
- OMNS / CLP-10003
- Conditions
- Dry Eye Syndromes, ATD, Sjogren's Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Financial constraints
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Epitech Mag Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 6 Jan 2021 (actual)
- Study completion
- 6 Jan 2021 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and effectiveness of Viveye OMNS non-invasive treatment for management of the signs and symptoms of severe dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single treatment | Active comparator | Device: Viveye OMNS treatmentA single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye. |
| Single sham treatment | Sham comparator | Device: Viveye OMNS sham treatmentA single treatment will be administered for both eyes for each subject. The treatment will be administered for 11 minutes per treated eye. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females, 18-80 years old
- Subjects with severe aqueous deficient dry eye disease (concomitant meibomian gland disease is permitted):
- No contact lens wear for at least seven days prior to the Screening Visit and willingness to forego contact lens wear for the duration of the study;
- Literacy, able to speak English or Hebrew, and able to complete questionnaires independently;
- Willing and able to sign the informed consent form and deemed capable of complying with the requirements of the study protocol (tests and follow-up visits).
Key exclusion criteria (5 listed)
- Significant anterior blepharitis including signs of Demodex eyelid infection;
- If the subject is using prescription dry eye ophthalmic drug such as Restasis (Cyclosporine A 0.05% ophthalmic emulsion), Xiidra (Lifitegrast), Cequa (Cyclosporine 0.09% ophthalmic solution), and the medication has not been used regularly for the past 3 months prior to screening visit;
- Change in eye lubricant type usage in the last 1 month prior enrollment. Use of any device to manage DED within 1 month of Screening Visit;
- Punctal plugs are present at screening that were inserted in the last 30 days prior enrollment, or intracanalicular plug that were inserted in the last 6 months in any eyelid;
- Corneal transplant in either or both eyes;
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 |
|---|---|---|
| Viveye OMNS treatmentThe Viveye OMNS treatment ( ~30 min) will be applied once, during the treatment visit only | Device | Single treatment |
| Viveye OMNS sham treatmentThe Viveye OMNS sham treatment ( ~30 min) will be applied once, during the treatment visit only | Device | Single sham treatment |
Primary outcome
Best corrected visual acuity (BCVA)
Time frame: 12 weeks
Frequency of treatment related deterioration in BCVA
Intraocular Pressure (IOP)
Time frame: 12 weeks
IOP results will be summarized descriptively. 95% confidence intervals for the difference between treatment arms at each visit will be presented, assuming t-distribution.
Slit lamp biomicroscopy
Time frame: 12 weeks
The percent related to worsening in ocular pathological changes observed
Rate of device/treatment related adverse events
Time frame: 12 weeks
Rate of device/treatment related Incidence of Adverse events (AE) will be presented in tabular form by seriousness, severity and relation to treatment
Fluorescein corneal staining
Time frame: 12 weeks
Change from baseline in fluorescein corneal staining score (NEI Scale 0-15) per treatment arm and visit (lower scores mean a better outcome.)
Ocular discomfort questionnaires
Time frame: 12 weeks
Change from baseline in ocular discomfort questionnaires (Standard Patient Evaluation of Eye Dryness - SPEED) per treatment arm and visit. score from 0 to 28, higher scores mean a worse outcome. (Reduction in SUM score = improvement)
Results and safety
The study was stopped early (reason given: Financial constraints). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viveye OMNS treatment in people with Dry Eye Syndromes and ATD, run by Epitech Mag Ltd. at 3 sites in Israel.
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 8 inclusion and 5 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Financial constraints). Results are not available in the source record.
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?
Best corrected visual acuity (BCVA) (time frame: 12 weeks). The study lists 6 primary outcomes in all. 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 21 Apr 2021.