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

NCT03012698 | Completed

• 1 other identifier: CA-10002
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity (BCVA)

  3 mounth

Study Arms (1)

RMS treatment

EXPERIMENTAL

Device: Ocular Repetitive Magnetic Stimulation (RMS) treatment

Interventions

Ocular Repetitive Magnetic Stimulation (RMS) treatment DEVICE

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.

RMS treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Epitech Mag Ltd.: lead

Study Sites (3)

E. Wolfson Medical Center

Holon, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Shaare Zedek Medical Center (SZMC)

Jerusalem, Israel

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome; Meibomian Gland Dysfunction

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eyelid Diseases

Study Officials

• Avi Solomon, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• David Zadok, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

• Haggay Avizemer, MD

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 6, 2017
• Study Start: November 1, 2017
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

IL (3)