<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/NCT01683318</url>
  </required_header>
  <id_info>
    <org_study_id>R913/22/2012</org_study_id>
    <nct_id>NCT01683318</nct_id>
  </id_info>
  <brief_title>Treatment of Meibomian Gland Dysfunction</brief_title>
  <official_title>Thermal Pulsation System for the Treatment of Meibomian Gland Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Singapore National Eye Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Singapore National Eye Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study aims to test the efficacy of treatment for a device that utilises a thermal&#xD;
      pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in&#xD;
      patients suffering from meibomian gland dysfunction.&#xD;
&#xD;
      Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators&#xD;
      will monitor them for changes in tear film and lipid composition, as well as changes in the&#xD;
      anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye&#xD;
      symptoms will be documented in form of questionnaires.&#xD;
&#xD;
      The investigators hypothesize that the treatment will be effective in improving clinical&#xD;
      signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian&#xD;
      Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to&#xD;
      patients in Singapore.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <primary_completion_date type="Actual">October 2013</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>ocular discomfort</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tear Break Up Time (TBUT)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of blocked meibomian glands</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal fluorescein staining score</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To measure the production of tears</measure>
    <time_frame>3 months</time_frame>
    <description>Schirmer's test uses paper strips inserted into the lower eyelid (conjunctival sac)for 5 minutes to measure the production of tears. Both eyes are tested at the same time. The paper is then removed and the amount of moisture is measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tear evaporimetry</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid layer thickness</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Meibomian Gland Dysfunction (MGD)</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thermal Pulsation therapy</intervention_name>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible&#xD;
             MG plug in the 4 eyelids, or discernable change in consistency of meibum (increased in&#xD;
             viscosity or opacity) when MG expressed in upper or lower eyelids.&#xD;
&#xD;
          2. At least one out of 8 questions on dry eye symptoms is answered with often or all the&#xD;
             time.&#xD;
&#xD;
          3. Eyes should not show any other ocular surface pathology which required more treatment&#xD;
             than eye lubricant and conventional eyelid hygiene.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known history of thyroid disorders (diagnosed by physician).&#xD;
&#xD;
          2. No ocular surgery within the previous 6 months and LASIK within the previous 1 year.&#xD;
&#xD;
          3. Any intake of central nervous system and hormonal drugs within last 30 days and&#xD;
             inability to withhold such drugs for at least 6 weeks.&#xD;
&#xD;
          4. Active ocular infection or pterygium.&#xD;
&#xD;
          5. Anticipated necessity to wear contact lens in the duration of the study.&#xD;
&#xD;
          6. Living in the same household as another participant of the study.&#xD;
&#xD;
          7. Any other specified reason as determined by clinical investigator, for example, the&#xD;
             need to use any treatment or eyedrops not permitted by the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Singapore National Eye Centre</name>
      <address>
        <city>Singapore</city>
        <zip>168751</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>November 11, 2013</last_update_submitted>
  <last_update_submitted_qc>November 11, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2013</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</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Meibomian Gland Dysfunction</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/NCT01683318
org study id: R913/22/2012
nct id: NCT01683318
lead sponsor: 
collaborator: 
has dmc: No
The current study aims to test the efficacy of treatment for a device that utilises a thermal
      pulsation system, which applies heat from the inner surface of the eyelids (Lipiflow) in
      patients suffering from meibomian gland dysfunction.

      Patients will be asked to undergo a one-time treatment with Lipiflow and the investigators
      will monitor them for changes in tear film and lipid composition, as well as changes in the
      anatomy of meibomian glands for over a study period of 12 weeks. Additionally, dry eye
      symptoms will be documented in form of questionnaires.

      The investigators hypothesize that the treatment will be effective in improving clinical
      signs and will relieve dry eye symptoms for the patient. If this method of managing Meibomian
      Gland Dysfunction (MGD) is found to be efficacious and safe, it will be made available to
      patients in Singapore.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ocular discomfort
time frame: 3 months
measure: Tear Break Up Time (TBUT)
time frame: 3 months
measure: Number of blocked meibomian glands
time frame: 3 months
measure: Corneal fluorescein staining score
time frame: 3 months
measure: To measure the production of tears
time frame: 3 months
description: Schirmer's test uses paper strips inserted into the lower eyelid (conjunctival sac)for 5 minutes to measure the production of tears. Both eyes are tested at the same time. The paper is then removed and the amount of moisture is measured.
measure: Tear evaporimetry
time frame: 3 months
measure: Lipid layer thickness
time frame: 3 months
arm group label: Treatment
arm group type: Experimental
description: Patients will undergo Thermal Pulsation treatment of Meibomian Gland Dysfunction using the TearScience System (Lipiflow).
intervention type: Procedure
intervention name: Thermal Pulsation therapy
arm group label: Treatment
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: Singapore National Eye Centre
investigator full name: Louis Tong
investigator title: Clinician-Scientist
mesh term: Meibomian Gland Dysfunction