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

November 21, 2019 updated by: Epitech Mag Ltd.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel
        • E. Wolfson Medical Center
      • Jerusalem, Israel
        • Hadassah Medical Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center (SZMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: RMS treatment
Device: Ocular Repetitive Magnetic Stimulation (RMS) treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity (BCVA)
Time Frame: 3 mounth
3 mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epitech Mag Ltd.

Investigators

  • Principal Investigator: Avi Solomon, MD, Hadassah Medical Organization
  • Principal Investigator: David Zadok, MD, Shaare Zedek Medical Center
  • Principal Investigator: Haggay Avizemer, MD, Wolfson medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ACTUAL)

June 17, 2019

Study Completion (ACTUAL)

June 17, 2019

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (ESTIMATE)

January 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA-10002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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