Dry EyeNCT03012698
Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye
A study testing Ocular Repetitive Magnetic Stimulation (RMS) treatment in people with Dry Eye and Sjogren's Syndrome, run by Epitech Mag Ltd. at 3 sites in Israel.
Trial summary
The study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic Stimulation Device on one eye in the first stage and both eyes sequentially in the second stage of the study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye, Sjogren's Syndrome, Aqueous Tear Deficiency
- What is being tested?
- Ocular Repetitive Magnetic Stimulation (RMS) treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesIsrael
- Study dates
- 1 Nov 2017to 17 Jun 2019
- 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 moderate to severe dry eye syndrome
- Subjects able to understand the requirements of the protocol and provide informed consent.
Who cannot join
- Eyes with other ocular surface pathology which requires more treatment than eye lubricant and conventional eyelid hygiene
- A concurrent ocular disease including ocular infection or pterygium.
- Ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- Any ocular injury or ocular Herpes infection within past 3 months
- Anticipated necessity to wear contact lens in the duration of the study.
- Unstable thyroid disorders (Drugs Tx not stable in the last 3 months).
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- Alcoholism
- Pregnant or nursing women
- Documented HIV positive
- Cardiac pacemakers, cardioverter defibrillators, or neurostimulators, cochlear implants, implanted medication pumps or intracardiac lines, implanted brain electrodes (cortical or deep-brain electrodes)
- Any Conductive, ferromagnetic or other magnetic - sensitive objects such as aneurysm clips or coils, stents, bullet fragments in the head or neck
- Significant heart disease or cerebrovascular disease
- History of epilepsy, dementia, head trauma, increased intracranial pressure, or central nervous system (CNS) tumors.
- Participation in another ophthalmic clinical trial within past 30 day
- Any other specified reason as determined by the clinical investigator.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
E. Wolfson Medical Center
Holon
Hadassah Medical Center
Jerusalem
Shaare Zedek Medical Center (SZMC)
Jerusalem
About this study
The study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic Stimulation Device on one eye in the first stage and both eyes sequentially in the second stage of the study. Changes are monitored for over a study period of 3 months.
- Conditions
- Dry Eye, Sjogren's Syndrome, Aqueous Tear Deficiency, Meibomian Gland Dysfunction, Dry Eye Syndromes
- Being tested
- Ocular Repetitive Magnetic Stimulation (RMS) treatment
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular Repetitive Magnetic Stimulation (RMS) treatmentDevice
First stage: Patients will be asked to undergo a one-time treatment with Epitech Corneal Magnetic Stimulation Device on one eye. The worst eye will be treated; if both eyes are equal, the right eye will be treated.
Second stage: will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.
| Study group | Role | What they receive |
|---|---|---|
| RMS treatment | Experimental | Not described Receives: Device: Ocular Repetitive Magnetic Stimulation (RMS) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA)
Measured: 3 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start1 Nov 2017
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Model description
- The study will include 30 patients enrolled in 2 stages. 1. The first 15 patients are treated in the more severe dry eye conditioned eye. 2. The remaining 15 patients will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epitech Mag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avi Solomon, MD, Principal investigator, Hadassah Medical OrganizationDavid Zadok, MD, Principal investigator, Shaare Zedek Medical CenterHaggay Avizemer, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012698
- Sponsor's protocol ID
- CA-10002
- Status last verified
- Nov 2019
- First submitted
- 4 Jan 2017
- Last updated
- 25 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT03012698
- Acronym / sponsor ID
- CA-10002
- Conditions
- Dry Eye, Sjogren's Syndrome, Aqueous Tear Deficiency, Meibomian Gland Dysfunction, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Epitech Mag Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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 study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic Stimulation Device on one eye in the first stage and both eyes sequentially in the second stage of the study. Changes are monitored for over a study period of 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will include 30 patients enrolled in 2 stages. 1. The first 15 patients are treated in the more severe dry eye conditioned eye. 2. The remaining 15 patients will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.
| Arm | Type | Receives |
|---|---|---|
| RMS treatment | Experimental | Device: Ocular Repetitive Magnetic Stimulation (RMS) treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, 18-80 years old
- Subjects with moderate to severe dry eye syndrome
- Subjects able to understand the requirements of the protocol and provide informed consent.
Key exclusion criteria (15 listed)
- Eyes with other ocular surface pathology which requires more treatment than eye lubricant and conventional eyelid hygiene
- A concurrent ocular disease including ocular infection or pterygium.
- Ocular surgery within the previous 6 months and LASIK within the previous 1 year.
- Any ocular injury or ocular Herpes infection within past 3 months
- Anticipated necessity to wear contact lens in the duration of 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 |
|---|---|---|
| Ocular Repetitive Magnetic Stimulation (RMS) treatmentFirst stage: Patients will be asked to undergo a one-time treatment with Epitech Corneal Magnetic Stimulation Device on one eye. The worst eye will be treated; if both eyes are equal, the right eye will be treated. Second stage: will be treated on both eyes, applying treatment to both eyes sequentially during the same visit. | Device | RMS treatment |
Primary outcome
Best Corrected Visual Acuity (BCVA)
Time frame: 3 mounth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
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.
Avi Solomon, MD principal investigator
Hadassah Medical Organization
David Zadok, MD principal investigator
Shaare Zedek Medical Center
Haggay Avizemer, MD principal investigator
Wolfson Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular Repetitive Magnetic Stimulation (RMS) treatment in people with Dry Eye and Sjogren's Syndrome, 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 3 inclusion and 15 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 25 Nov 2019. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 3 mounth). 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 25 Nov 2019; AzTrials last refreshed its copy on 2 Nov 2026.