<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03012698</url>
  </required_header>
  <id_info>
    <org_study_id>CA-10002</org_study_id>
    <nct_id>NCT03012698</nct_id>
  </id_info>
  <brief_title>Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye</brief_title>
  <official_title>Pilot Study for Testing Safety of Repetitive Magnetic Stimulation for Treatment of Dry Eye</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Epitech Mag Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Epitech Mag Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to test the safety of Repetitive Magnetic Stimulation (RMS) treatment for dry&#xD;
      eye disease. Patients are asked to undergo a one-time treatment with Epitech Ocular Magnetic&#xD;
      Stimulation Device on one eye in the first stage and both eyes sequentially in the second&#xD;
      stage of the study. Changes are monitored for over a study period of 3 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">June 17, 2019</completion_date>
  <primary_completion_date type="Actual">June 17, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The study will include 30 patients enrolled in 2 stages.&#xD;
The first 15 patients are treated in the more severe dry eye conditioned eye.&#xD;
The remaining 15 patients will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Best Corrected Visual Acuity (BCVA)</measure>
    <time_frame>3 mounth</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Dry Eye</condition>
  <condition>Sjogren's Syndrome</condition>
  <condition>Aqueous Tear Deficiency</condition>
  <condition>Meibomian Gland Dysfunction</condition>
  <condition>Dry Eye Syndromes</condition>
  <arm_group>
    <arm_group_label>RMS treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ocular Repetitive Magnetic Stimulation (RMS) treatment</intervention_name>
    <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.&#xD;
Second stage: will be treated on both eyes, applying treatment to both eyes sequentially during the same visit.</description>
    <arm_group_label>RMS treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females, 18-80 years old&#xD;
&#xD;
          2. Subjects with moderate to severe dry eye syndrome&#xD;
&#xD;
          3. Subjects able to understand the requirements of the protocol and provide informed&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Eyes with other ocular surface pathology which requires more treatment than eye&#xD;
             lubricant and conventional eyelid hygiene&#xD;
&#xD;
          2. A concurrent ocular disease including ocular infection or pterygium.&#xD;
&#xD;
          3. Ocular surgery within the previous 6 months and LASIK within the previous 1 year.&#xD;
&#xD;
          4. Any ocular injury or ocular Herpes infection within past 3 months&#xD;
&#xD;
          5. Anticipated necessity to wear contact lens in the duration of the study.&#xD;
&#xD;
          6. Unstable thyroid disorders (Drugs Tx not stable in the last 3 months).&#xD;
&#xD;
          7. Alcoholism&#xD;
&#xD;
          8. Pregnant or nursing women&#xD;
&#xD;
          9. Documented HIV positive&#xD;
&#xD;
         10. Cardiac pacemakers, cardioverter defibrillators, or neurostimulators, cochlear&#xD;
             implants, implanted medication pumps or intracardiac lines, implanted brain electrodes&#xD;
             (cortical or deep-brain electrodes)&#xD;
&#xD;
         11. Any Conductive, ferromagnetic or other magnetic - sensitive objects such as aneurysm&#xD;
             clips or coils, stents, bullet fragments in the head or neck&#xD;
&#xD;
         12. Significant heart disease or cerebrovascular disease&#xD;
&#xD;
         13. History of epilepsy, dementia, head trauma, increased intracranial pressure, or&#xD;
             central nervous system (CNS) tumors.&#xD;
&#xD;
         14. Participation in another ophthalmic clinical trial within past 30 day&#xD;
&#xD;
         15. Any other specified reason as determined by the clinical investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Avi Solomon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Zadok, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shaare Zedek Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Haggay Avizemer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolfson Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>E. Wolfson Medical Center</name>
      <address>
        <city>Holon</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shaare Zedek Medical Center (SZMC)</name>
      <address>
        <city>Jerusalem</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>November 21, 2019</last_update_submitted>
  <last_update_submitted_qc>November 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03012698
org study id: CA-10002
nct id: NCT03012698
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
intervention 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.
primary purpose: Treatment
masking: None (Open Label)
measure: Best Corrected Visual Acuity (BCVA)
time frame: 3 mounth
arm group label: RMS treatment
arm group type: Experimental
intervention type: Device
intervention name: Ocular Repetitive Magnetic Stimulation (RMS) treatment
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.
arm group label: RMS treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Avi Solomon, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
last name: David Zadok, MD
role: Principal Investigator
affiliation: Shaare Zedek Medical Center
last name: Haggay Avizemer, MD
role: Principal Investigator
affiliation: Wolfson Medical Center
facility: 
facility: 
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Meibomian Gland Dysfunction
mesh term: Syndrome