<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/NCT02203188</url>
  </required_header>
  <id_info>
    <org_study_id>20000</org_study_id>
    <nct_id>NCT02203188</nct_id>
  </id_info>
  <brief_title>Effect of Debridement-scaling on the Relief of Dry Eye Signs and Symptoms in Sjogren's Syndrome</brief_title>
  <acronym>TOYOTA</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sjogren's Society of Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Waterloo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sjogren's Syndrome is an autoimmune condition in which the body attacks its own glands in the&#xD;
      body. Some of these glands are responsible for providing lubrication for the eye. As a&#xD;
      result, individuals with Sjogren's Syndrome often experience dry eye. Recently, a study had&#xD;
      shown that dry eye symptoms were improved by removing debris and old skin cells along the&#xD;
      eyelid margin. This technique is called eyelid debridement-scaling. The purpose of this study&#xD;
      is to determine how well this technique works in improving dry eye signs and symptoms in&#xD;
      individuals with Sjogren's Syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Meibomian gland score (MGS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Meibomian gland score (MGS)</measure>
    <time_frame>1 month after baseline and/or treatment</time_frame>
    <description>Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SICCA Ocular Staining Score</measure>
    <time_frame>Baseline</time_frame>
    <description>Prior to treatment (if applicable). Based on corneal and conjunctival staining. Total scores range 0 to 12 with 0 being no staining and 12 being high staining.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SICCA Ocular Staining Score</measure>
    <time_frame>1 month after baseline and/or treatment</time_frame>
    <description>Based on corneal and conjunctival staining. Total scores range 0 to 12 with 0 being no staining and 12 being high staining.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Surface Disease Index Score (OSDI)</measure>
    <time_frame>Baseline</time_frame>
    <description>Prior to treatment (if applicable). The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ocular Surface Disease Index Score (OSDI)</measure>
    <time_frame>1 month after baseline/treatment</time_frame>
    <description>The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals &quot;none of the time&quot; and 4 equals &quot;all of the time&quot;. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Meibomian gland yielding liquid secretions (MGYLS)</measure>
    <time_frame>Baseline</time_frame>
    <description>Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Meibomian gland yielding liquid secretions (MGYLS)</measure>
    <time_frame>1 month after baseline/treatment</time_frame>
    <description>MGYLS is the number of glands with MGS grade 2 or higher.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Assessment iN Dry Eye score</measure>
    <time_frame>Baseline</time_frame>
    <description>Prior to treatment (if applicable). A short questionnaire based on a visual analog scale (VAS) to quantify the frequency and severity of symptoms of dry eye syndrome. The &quot;Symptom Assessment iN Dry Eye&quot; (SANDE) questionnaire utilizes a 100 mm horizontal VAS technique to quantify patient symptoms of ocular dryness and/or irritation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom Assessment iN Dry Eye score</measure>
    <time_frame>1 month after baseline and/or treatment</time_frame>
    <description>A short questionnaire based on a visual analog scale (VAS) to quantify the frequency and severity of symptoms of dry eye syndrome. The &quot;Symptom Assessment iN Dry Eye&quot; (SANDE) questionnaire utilizes a 100 mm horizontal VAS technique to quantify patient symptoms of ocular dryness and/or irritation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Sjogren's Syndrome</condition>
  <arm_group>
    <arm_group_label>Lid debridgement scaling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Perform lid debridgement scaling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lid debridgement scaling</intervention_name>
    <arm_group_label>Lid debridgement scaling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is at least 17 years of age and has full legal capacity to volunteer;&#xD;
&#xD;
          -  Has read and signed an information consent letter;&#xD;
&#xD;
          -  Is willing and able to follow instructions and maintain the appointment schedule;&#xD;
&#xD;
          -  Is diagnosed with Sjogren's Syndrome;&#xD;
&#xD;
          -  Meibomian gland score of ≤ 9 (out of 15);&#xD;
&#xD;
          -  OSDI ≥ 23;&#xD;
&#xD;
          -  Willing to maintain the use of OTC medications throughout the course of the study&#xD;
&#xD;
          -  Have not worn contact lenses within the past 3 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is participating in any concurrent clinical or research study;&#xD;
&#xD;
          -  Has any known active* ocular disease and/or infection;&#xD;
&#xD;
          -  Has a systemic condition, other than Sjogren's Syndrome and its associated conditions,&#xD;
             that in the opinion of the investigator may affect a study outcome variable;&#xD;
&#xD;
          -  Is using any systemic or topical medications, other than those indicated for Sjogren's&#xD;
             Syndrome and its associated conditions, that in the opinion of the investigator may&#xD;
             affect a study outcome variable;&#xD;
&#xD;
          -  Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;&#xD;
&#xD;
          -  Is pregnant, lactating or planning a pregnancy at the time of enrolment;&#xD;
&#xD;
          -  Is aphakic;&#xD;
&#xD;
          -  Has undergone refractive error surgery; * For the purposes of this study, active&#xD;
             ocular disease is defined as infection or inflammation which requires therapeutic&#xD;
             treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae),&#xD;
             corneal and conjunctival staining and dry eye are not considered active ocular&#xD;
             disease. Neovascularization and corneal scars are the result of previous hypoxia,&#xD;
             infection or inflammation and are therefore not active.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lyndon Jones, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CCLR, University of Waterloo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Contact Lens Research, University of Waterloo</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <zip>N2L 3G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>July 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>December 18, 2014</last_update_submitted>
  <last_update_submitted_qc>December 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2014</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>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/NCT02203188
org study id: 20000
nct id: NCT02203188
lead sponsor: 
collaborator: 
has dmc: No
Sjogren's Syndrome is an autoimmune condition in which the body attacks its own glands in the
      body. Some of these glands are responsible for providing lubrication for the eye. As a
      result, individuals with Sjogren's Syndrome often experience dry eye. Recently, a study had
      shown that dry eye symptoms were improved by removing debris and old skin cells along the
      eyelid margin. This technique is called eyelid debridement-scaling. The purpose of this study
      is to determine how well this technique works in improving dry eye signs and symptoms in
      individuals with Sjogren's Syndrome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Meibomian gland score (MGS)
time frame: Baseline
description: Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
measure: Meibomian gland score (MGS)
time frame: 1 month after baseline and/or treatment
description: Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
measure: SICCA Ocular Staining Score
time frame: Baseline
description: Prior to treatment (if applicable). Based on corneal and conjunctival staining. Total scores range 0 to 12 with 0 being no staining and 12 being high staining.
measure: SICCA Ocular Staining Score
time frame: 1 month after baseline and/or treatment
description: Based on corneal and conjunctival staining. Total scores range 0 to 12 with 0 being no staining and 12 being high staining.
measure: Ocular Surface Disease Index Score (OSDI)
time frame: Baseline
description: Prior to treatment (if applicable). The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
measure: Ocular Surface Disease Index Score (OSDI)
time frame: 1 month after baseline/treatment
description: The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
measure: Meibomian gland yielding liquid secretions (MGYLS)
time frame: Baseline
description: Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.
measure: Meibomian gland yielding liquid secretions (MGYLS)
time frame: 1 month after baseline/treatment
description: MGYLS is the number of glands with MGS grade 2 or higher.
measure: Symptom Assessment iN Dry Eye score
time frame: Baseline
description: Prior to treatment (if applicable). A short questionnaire based on a visual analog scale (VAS) to quantify the frequency and severity of symptoms of dry eye syndrome. The "Symptom Assessment iN Dry Eye" (SANDE) questionnaire utilizes a 100 mm horizontal VAS technique to quantify patient symptoms of ocular dryness and/or irritation.
measure: Symptom Assessment iN Dry Eye score
time frame: 1 month after baseline and/or treatment
description: A short questionnaire based on a visual analog scale (VAS) to quantify the frequency and severity of symptoms of dry eye syndrome. The "Symptom Assessment iN Dry Eye" (SANDE) questionnaire utilizes a 100 mm horizontal VAS technique to quantify patient symptoms of ocular dryness and/or irritation.
arm group label: Lid debridgement scaling
arm group type: Experimental
description: Perform lid debridgement scaling
arm group label: Control
arm group type: No Intervention
description: No Treatment
intervention type: Procedure
intervention name: Lid debridgement scaling
arm group label: Lid debridgement scaling
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: No
last name: Lyndon Jones, PhD
role: Principal Investigator
affiliation: CCLR, University of Waterloo
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Syndrome