<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/NCT01692652</url>
  </required_header>
  <id_info>
    <org_study_id>4-2012-0463</org_study_id>
    <nct_id>NCT01692652</nct_id>
  </id_info>
  <brief_title>Changes of Inflammatory Cytokines in the Tears of Moderate and Severe MGD Treated With Topical Loteprednol Etabonate</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative&#xD;
      dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular&#xD;
      symptoms, which are all associated with the constant release of inflammatory mediators. To&#xD;
      our knowledge, there has been no study on tear cytokine levels in MGD patients treated with&#xD;
      topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear&#xD;
      cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical&#xD;
      loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine&#xD;
      the concentration of inflammatory tear cytokines in patients with MGD and to compare the&#xD;
      changes in tear cytokine levels between topical loteprednol etabonate and warm compress&#xD;
      treatment group and warm compress only treatment group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of inflammatory cytokines in the tears of moderate and severe MGD</measure>
    <time_frame>1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate</time_frame>
    <description>Cytokines were measured using the BD Cytometric Bead Array (CBA) (BD Bioscience, San Jose, CA). The cytokines analyzedwere IL-6, IL-7, IL-8, IL-1β, IL-17α, MCP-1, TNF-α, IL-12p70, and IFN-γ. Briefly, 20 μL tear fluid was thawed and added to a 50 μL mixture containing each capture antibody-bead reagent and 50 μL detector antibody-phycoerithrin (Ab-PE) reagent. The mixture was subsequently incubated for 3 h at room temperature, and washed to remove unbound detector Ab-PE reagent before flow cytometry. Data were acquired and analyzed using BD CBA software that calculates the cytokine concentration based on the standard curves and a four-parameter logistic curve-fitting model. Flow cytometry was performed using the BDTM LSRII system (BD Bioscience, San Jose, CA).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)</condition>
  <arm_group>
    <arm_group_label>Lotemax with warm compress group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>topical loteprednol etabonate (lotemax 0.5%) qid and warm compress &amp; ocular massage (a minimum of four times, once or twice a daily) for 2months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>warm compress only group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>warm compress only group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>topical loteprednol etabonate (lotemax 0.5%) with warm compress &amp; ocular massage</intervention_name>
    <arm_group_label>Lotemax with warm compress group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>warm compress only group</intervention_name>
    <arm_group_label>warm compress only group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        (1) stage 3 or 4 meibomian gland dysfunction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. history of previous ocular or intraocular surgery&#xD;
&#xD;
          2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease,&#xD;
&#xD;
          3. history of intolerance or hypersensitivity to any component of the study medications,&#xD;
&#xD;
          4. wearing contact lenses during the study period, presence of current punctal occlusion,&#xD;
&#xD;
          5. pregnancy, lactating women, and children.&#xD;
&#xD;
          6. Additionally, patients were excluded if they were using any topical ocular or systemic&#xD;
             medication that could be used for the treatment MGD or dry eye, including topical or&#xD;
             oral antibiotics, topical cyclosporine A, topical or oral steroids, topical&#xD;
             non-steroidal anti-inflammatory drugs, topical ocular allergy medications or&#xD;
             artificial tears&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>department of Ophthalmology, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>February 17, 2014</last_update_submitted>
  <last_update_submitted_qc>February 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Loteprednol Etabonate</mesh_term>
  </intervention_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/NCT01692652
org study id: 4-2012-0463
nct id: NCT01692652
lead sponsor: 
has dmc: No
Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative
      dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular
      symptoms, which are all associated with the constant release of inflammatory mediators. To
      our knowledge, there has been no study on tear cytokine levels in MGD patients treated with
      topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear
      cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical
      loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine
      the concentration of inflammatory tear cytokines in patients with MGD and to compare the
      changes in tear cytokine levels between topical loteprednol etabonate and warm compress
      treatment group and warm compress only treatment group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes of inflammatory cytokines in the tears of moderate and severe MGD
time frame: 1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate
description: Cytokines were measured using the BD Cytometric Bead Array (CBA) (BD Bioscience, San Jose, CA). The cytokines analyzedwere IL-6, IL-7, IL-8, IL-1β, IL-17α, MCP-1, TNF-α, IL-12p70, and IFN-γ. Briefly, 20 μL tear fluid was thawed and added to a 50 μL mixture containing each capture antibody-bead reagent and 50 μL detector antibody-phycoerithrin (Ab-PE) reagent. The mixture was subsequently incubated for 3 h at room temperature, and washed to remove unbound detector Ab-PE reagent before flow cytometry. Data were acquired and analyzed using BD CBA software that calculates the cytokine concentration based on the standard curves and a four-parameter logistic curve-fitting model. Flow cytometry was performed using the BDTM LSRII system (BD Bioscience, San Jose, CA).
arm group label: Lotemax with warm compress group
arm group type: Experimental
description: topical loteprednol etabonate (lotemax 0.5%) qid and warm compress & ocular massage (a minimum of four times, once or twice a daily) for 2months
arm group label: warm compress only group
arm group type: Active Comparator
description: warm compress only group
intervention type: Drug
intervention name: topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage
arm group label: Lotemax with warm compress group
intervention type: Other
intervention name: warm compress only group
arm group label: warm compress only group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Loteprednol Etabonate