<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/NCT03291704</url>
  </required_header>
  <id_info>
    <org_study_id>Meibomian Gland Dysfunction</org_study_id>
    <nct_id>NCT03291704</nct_id>
  </id_info>
  <brief_title>Investigating the Effect of At Home Thermal Therapy on Dry Eye Patients With Meibomian Gland Dysfunction</brief_title>
  <official_title>PILOT STUDY: The Effect of Thermal Therapy Using a Rechargeable, Wireless Device on Meibomian Gland Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UMay Care Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UMay Care Inc.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to determine the feasibility of at home thermal therapy&#xD;
      with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.&#xD;
&#xD;
      This will be done by assessing patients for improvement in symptoms and ocular oil gland&#xD;
      function after 4 weeks of a daily thermal therapy application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a non-randomized, open label study of subjects with documented MGD. All&#xD;
      subjects will be sent home with a wireless, portable thermal therapy device and examined pre&#xD;
      and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes&#xD;
      daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and&#xD;
      symptomatic change in their MGD as well as changes to their sleep quality and anxiety index.&#xD;
      Subjects will also be followed after treatment has been completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2018</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds</measure>
    <time_frame>Before and after 4 weeks of daily treatment</time_frame>
    <description>Ocular surface analysis of tear film evaporation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Ocular Surface Disease Index (OSDI) Score</measure>
    <time_frame>Before and after 4 weeks of daily treatment</time_frame>
    <description>Standardized symptom questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meibum Expressibility</measure>
    <time_frame>Before and after 4 weeks of daily treatment</time_frame>
    <description>Grade of Meibum oil expressibility from Meibomian Gland</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep Quality</measure>
    <time_frame>Before and after 4 weeks of daily treatment</time_frame>
    <description>Pittsburg Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State Trait and Anxiety</measure>
    <time_frame>Before and after 4 weeks of daily treatment</time_frame>
    <description>State-Trait Anxiety Index (STAI)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Meibomian Gland Dysfunction</condition>
  <condition>Dry Eye Disease</condition>
  <arm_group>
    <arm_group_label>Thermal Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heat application using at home thermal therapy device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermal therapy device</intervention_name>
    <description>Thermal therapy of blocked Meibomian glands</description>
    <arm_group_label>Thermal Therapy</arm_group_label>
    <other_name>umayREST</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of MGD&#xD;
&#xD;
          -  Minimum age 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of ocular disease, trauma, surgery (other than refractive), orbital cancer&#xD;
&#xD;
          -  3 month history of ocular infection and/or ocular inflammation not associated with dry&#xD;
             eye&#xD;
&#xD;
          -  3 month history of any active physician administered or prescription dry eye treatment&#xD;
&#xD;
          -  Pregnant, potentially pregnant or nursing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hermina Strungaru, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sharmin Habib, OD</last_name>
    <phone>5875017422</phone>
    <email>sharmin@umay.care</email>
  </overall_contact>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>March 15, 2018</last_update_submitted>
  <last_update_submitted_qc>March 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dry Eye</keyword>
  <keyword>Thermal Therapy</keyword>
  <keyword>Meibomian Gland Dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Meibomian Gland Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03291704
org study id: Meibomian Gland Dysfunction
nct id: NCT03291704
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this pilot study is to determine the feasibility of at home thermal therapy
      with a wireless, portable device, as an effective management of Meibomian Gland Dysfunction.

      This will be done by assessing patients for improvement in symptoms and ocular oil gland
      function after 4 weeks of a daily thermal therapy application.
This study will be a non-randomized, open label study of subjects with documented MGD. All
      subjects will be sent home with a wireless, portable thermal therapy device and examined pre
      and post treatment period. Subjects will be asked to use the device at bedtime for 5 minutes
      daily for 4 weeks. After treatment subjects will be re-examined and measured for clinical and
      symptomatic change in their MGD as well as changes to their sleep quality and anxiety index.
      Subjects will also be followed after treatment has been completed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Non-Invasive Tear Film Break Up Time (NITFBUT) in Seconds
time frame: Before and after 4 weeks of daily treatment
description: Ocular surface analysis of tear film evaporation
measure: Change in Ocular Surface Disease Index (OSDI) Score
time frame: Before and after 4 weeks of daily treatment
description: Standardized symptom questionnaire
measure: Meibum Expressibility
time frame: Before and after 4 weeks of daily treatment
description: Grade of Meibum oil expressibility from Meibomian Gland
measure: Sleep Quality
time frame: Before and after 4 weeks of daily treatment
description: Pittsburg Sleep Quality Index (PSQI)
measure: State Trait and Anxiety
time frame: Before and after 4 weeks of daily treatment
description: State-Trait Anxiety Index (STAI)
arm group label: Thermal Therapy
arm group type: Experimental
description: Heat application using at home thermal therapy device
intervention type: Device
intervention name: Thermal therapy device
description: Thermal therapy of blocked Meibomian glands
arm group label: Thermal Therapy
other name: umayREST
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hermina Strungaru, MD
role: Principal Investigator
affiliation: University of Alberta
last name: Sharmin Habib, OD
phone: 5875017422
email: sharmin@umay.care
responsible party type: Sponsor
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
mesh term: Meibomian Gland Dysfunction
sharing ipd: Undecided