<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/NCT04451122</url>
  </required_header>
  <id_info>
    <org_study_id>demodicosis WDD</org_study_id>
    <nct_id>NCT04451122</nct_id>
  </id_info>
  <brief_title>Treatment of Ocular Demodicosis by Cleansing the Eyelid Margins Combined With Tea Tree Oil Ointment</brief_title>
  <official_title>Treatment of Ocular Demodicosis by Cleansing the Eyelid Margins Combined With Tea Tree Oil Ointment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wenzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wenzhou Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate whether the cleaning of eyelid margins increases the effectiveness of&#xD;
      traditional tea tree oil eyelid margins in treating mites. The investigators randomly divided&#xD;
      60 participants into two groups: Group A was treated with traditional tea tree oil eyelid&#xD;
      margin, Group B was treated with traditional tea tree oil eyelid margin + eyelid cleansing,&#xD;
      and participants were rechecked after 3 months of regular medication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</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>The severity of dry eyes</measure>
    <time_frame>3 months</time_frame>
    <description>OSDI dry eye questionnaire</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Mite-Borne</condition>
  <arm_group>
    <arm_group_label>Treatment of ocular demodicosis</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cleansing the eyelid margins</intervention_name>
    <description>using eyelid cleaning wipes to cleansing the eyelid margins</description>
    <arm_group_label>Treatment of ocular demodicosis</arm_group_label>
    <other_name>tea tree oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosisof ocular surface mite parasitism&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any acute keratoconjunctivitis;c dacryocystitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eye Hospital of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dandan Wang, MD</last_name>
      <phone>18258227706</phone>
      <email>wangdan4827716@yahoo.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>April 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wenzhou Medical University</investigator_affiliation>
    <investigator_full_name>yin ying zhao</investigator_full_name>
    <investigator_title>Researcher；clinical research center</investigator_title>
  </responsible_party>
  <keyword>eyelid margins</keyword>
  <keyword>ocular demodicosis</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tea Tree Oil</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/NCT04451122
org study id: demodicosis WDD
nct id: NCT04451122
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate whether the cleaning of eyelid margins increases the effectiveness of
      traditional tea tree oil eyelid margins in treating mites. The investigators randomly divided
      60 participants into two groups: Group A was treated with traditional tea tree oil eyelid
      margin, Group B was treated with traditional tea tree oil eyelid margin + eyelid cleansing,
      and participants were rechecked after 3 months of regular medication.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The severity of dry eyes
time frame: 3 months
description: OSDI dry eye questionnaire
arm group label: Treatment of ocular demodicosis
arm group type: Other
intervention type: Other
intervention name: cleansing the eyelid margins
description: using eyelid cleaning wipes to cleansing the eyelid margins
arm group label: Treatment of ocular demodicosis
other name: tea tree oil
criteria: 
gender: All
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Wenzhou Medical University
investigator full name: yin ying zhao
investigator title: Researcher；clinical research center
mesh term: Tea Tree Oil