Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye

Conditions
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Dry Eye, Sjogren's Syndrome, Aqueous Tear Deficiency, Meibomian Gland Dysfunction, Dry Eye Syndromes

Intervention / Treatment
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* Device: Ocular Repetitive Magnetic Stimulation (RMS) treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study will include 30 patients enrolled in 2 stages. The first 15 patients are treated in the more severe dry eye conditioned eye. The remaining 15 patients will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RMS treatment<br> | Device: Ocular Repetitive Magnetic Stimulation (RMS) treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity (BCVA) |  | 3 mounth |