<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/NCT03840668</url>
  </required_header>
  <id_info>
    <org_study_id>R1507/6/2018</org_study_id>
    <secondary_id>2018/2102</secondary_id>
    <nct_id>NCT03840668</nct_id>
  </id_info>
  <brief_title>Acceptability of the Use of USB-Powered Eye Mask</brief_title>
  <official_title>Acceptance and Monitoring of the Use of USB-Powered Eye Mask</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore National Eye Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ngee Ann Polytechnic Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Singapore National Eye Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid&#xD;
      warming at home. Such eyemasks can be plugged into a copyrighted device developed in&#xD;
      collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary&#xD;
      device transmits a signal to an online database whenever the device is used. Through our&#xD;
      copyrighted Android/ iOS application, you or your physician can monitor the frequency of&#xD;
      eyelid warming over a long period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dry eye is a very common condition that can cause blurring of vision associated with reading,&#xD;
      grittiness, eyelid heaviness and poor tolerance of light. Up to 80% of dry eye is due to&#xD;
      blocked oil glands in the eyelids known as Meibomian Gland Dysfunction (MGD) and scientific&#xD;
      studies have shown that sustained eyelid warming at 40-42°C for at least 8 minutes a day is&#xD;
      effective to control this condition and increase the tear film layer thickness.&#xD;
&#xD;
      Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid&#xD;
      warming at home. Such eyemasks can be plugged into a copyrighted device developed in&#xD;
      collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary&#xD;
      device transmits a signal to an online database whenever the device is used. Through our&#xD;
      copyrighted Android/ iOS application, you or your physician can monitor the frequency of&#xD;
      eyelid warming over a long period. To further encourage eyelid warming to be performed more&#xD;
      frequently, the signal can also be sent to a participating games server which hastens&#xD;
      progress in the game. Thus, addiction to online games, which usually worsens symptoms of dry&#xD;
      eye can now be a way to treat dry eye.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2023</start_date>
  <completion_date type="Anticipated">November 2024</completion_date>
  <primary_completion_date type="Anticipated">November 2024</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptance of USB eyemask questionnaire</measure>
    <time_frame>14 days</time_frame>
    <description>Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Dry Eye</condition>
  <arm_group>
    <arm_group_label>Dry eye</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who will be using the USB-powered eye mask.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>USB Eye Mask</intervention_name>
    <description>To evaluate the acceptance of the USB eye mask via questionnaire and also to monitor the use of USB eye mask over a period of 3 months.</description>
    <arm_group_label>Dry eye</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects must be 21 years or older.&#xD;
&#xD;
          2. Subject must have severe MGD&#xD;
&#xD;
          3. Subject must be willing to answer the questions in the questionnaire&#xD;
&#xD;
          4. Subject must be willing to use the USB-powered eyemask as instructed&#xD;
&#xD;
          5. Subject must have the ability to provide informed consent&#xD;
&#xD;
          6. Subject must be willing to come back for follow-up visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any other specified reason as determined by the clinical investigator.&#xD;
&#xD;
          2. Is pregnant, lactating or planning a pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Louis Tong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Singapore Eye Research Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Louis Tong, PhD</last_name>
    <phone>65767200</phone>
    <email>louis.tong.h.t@singhealth.com.sg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cynthia Boo, BSc</last_name>
    <phone>65767200</phone>
    <email>cynthia.boo.s.k@seri.com.sg</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Singapore Eye Research Institute</name>
      <address>
        <city>Singapore</city>
        <zip>169856</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Singapore National Eye Centre</investigator_affiliation>
    <investigator_full_name>Louis Tong</investigator_full_name>
    <investigator_title>Clinician-Scientist, Senior Consultant</investigator_title>
  </responsible_party>
  <keyword>USB eyemask</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</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/NCT03840668
org study id: R1507/6/2018
secondary id: 2018/2102
nct id: NCT03840668
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid
      warming at home. Such eyemasks can be plugged into a copyrighted device developed in
      collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary
      device transmits a signal to an online database whenever the device is used. Through our
      copyrighted Android/ iOS application, you or your physician can monitor the frequency of
      eyelid warming over a long period.
Dry eye is a very common condition that can cause blurring of vision associated with reading,
      grittiness, eyelid heaviness and poor tolerance of light. Up to 80% of dry eye is due to
      blocked oil glands in the eyelids known as Meibomian Gland Dysfunction (MGD) and scientific
      studies have shown that sustained eyelid warming at 40-42°C for at least 8 minutes a day is
      effective to control this condition and increase the tear film layer thickness.

      Portable USB-powered eyemasks provide convenience to dry eye sufferers to perform eyelid
      warming at home. Such eyemasks can be plugged into a copyrighted device developed in
      collaboration with Ngee Ann Polytechnic that tracks patients' usage. This revolutionary
      device transmits a signal to an online database whenever the device is used. Through our
      copyrighted Android/ iOS application, you or your physician can monitor the frequency of
      eyelid warming over a long period. To further encourage eyelid warming to be performed more
      frequently, the signal can also be sent to a participating games server which hastens
      progress in the game. Thus, addiction to online games, which usually worsens symptoms of dry
      eye can now be a way to treat dry eye.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Acceptance of USB eyemask questionnaire
time frame: 14 days
description: Participants will be asked to answer some questionnaires on acceptance and evaluation of USB eye mask
arm group label: Dry eye
arm group type: Experimental
description: Participants who will be using the USB-powered eye mask.
intervention type: Device
intervention name: USB Eye Mask
description: To evaluate the acceptance of the USB eye mask via questionnaire and also to monitor the use of USB eye mask over a period of 3 months.
arm group label: Dry eye
criteria: 
gender: All
minimum age: 21 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Louis Tong, PhD
role: Principal Investigator
affiliation: Singapore Eye Research Institute
last name: Louis Tong, PhD
phone: 65767200
email: louis.tong.h.t@singhealth.com.sg
last name: Cynthia Boo, BSc
phone: 65767200
email: cynthia.boo.s.k@seri.com.sg
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Singapore National Eye Centre
investigator full name: Louis Tong
investigator title: Clinician-Scientist, Senior Consultant
mesh term: Dry Eye Syndromes