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

Primary Purpose

Dry Eye, Sjogren's Syndrome, Aqueous Tear Deficiency

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ocular Repetitive Magnetic Stimulation (RMS) treatment
Sponsored by
Epitech Mag Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • E. Wolfson Medical Center
  • Hadassah Medical Center
  • Shaare Zedek Medical Center (SZMC)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RMS treatment

Arm Description

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity (BCVA)

Secondary Outcome Measures

Full Information

First Posted
January 4, 2017
Last Updated
November 21, 2019
Sponsor
Epitech Mag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03012698
Brief Title
Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye
Official Title
Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 17, 2019 (Actual)
Study Completion Date
June 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Epitech Mag Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Sjogren's Syndrome, Aqueous Tear Deficiency, Meibomian Gland Dysfunction, Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RMS treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Ocular Repetitive Magnetic Stimulation (RMS) treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity (BCVA)
Time Frame
3 mounth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi Solomon, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Zadok, MD
Organizational Affiliation
Shaare Zedek Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haggay Avizemer, MD
Organizational Affiliation
Wolfson Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
E. Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Shaare Zedek Medical Center (SZMC)
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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