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

EpiTech Mag

Status: Completed

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

Treatments: Device: Ocular Repetitive Magnetic Stimulation (RMS) treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT03012698

CA-10002

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Males and females, 18-80 years old
2. Subjects with moderate to severe dry eye syndrome
3. Subjects able to understand the requirements of the protocol and provide informed consent.

Exclusion criteria

1. Eyes with other ocular surface pathology which requires more treatment than eye lubricant and conventional eyelid hygiene
2. A concurrent ocular disease including ocular infection or pterygium.
3. Ocular surgery within the previous 6 months and LASIK within the previous 1 year.
4. Any ocular injury or ocular Herpes infection within past 3 months
5. Anticipated necessity to wear contact lens in the duration of the study.
6. Unstable thyroid disorders (Drugs Tx not stable in the last 3 months).
7. Alcoholism
8. Pregnant or nursing women
9. Documented HIV positive
10. Cardiac pacemakers, cardioverter defibrillators, or neurostimulators, cochlear implants, implanted medication pumps or intracardiac lines, implanted brain electrodes (cortical or deep-brain electrodes)
11. Any Conductive, ferromagnetic or other magnetic - sensitive objects such as aneurysm clips or coils, stents, bullet fragments in the head or neck
12. Significant heart disease or cerebrovascular disease
13. History of epilepsy, dementia, head trauma, increased intracranial pressure, or central nervous system (CNS) tumors.
14. Participation in another ophthalmic clinical trial within past 30 day
15. Any other specified reason as determined by the clinical investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

RMS treatment

Experimental group

Treatment:

Device: Ocular Repetitive Magnetic Stimulation (RMS) treatment