<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/NCT04478955</url>
  </required_header>
  <id_info>
    <org_study_id>Corum State Hospital</org_study_id>
    <nct_id>NCT04478955</nct_id>
  </id_info>
  <brief_title>Effect of Eye Make up on Ocular Surface</brief_title>
  <official_title>Effect of Pencil Eyeliners and Waterproof Mascara on Tear Stability Tests and Meibomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erol Olcok Corum Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Erol Olcok Corum Training and Research Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the degree of tear film instability and severity of&#xD;
      meibomian gland loss between subjects who use eyeliner, mascara, a combination of both and&#xD;
      those who do not use eyeliner.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 29, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Schirmer test</measure>
    <time_frame>5 minutes</time_frame>
    <description>Tear measurement</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non contact tear break up test</measure>
    <time_frame>17 seconds</time_frame>
    <description>tear stability calculation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meibomography</measure>
    <time_frame>2 minutes</time_frame>
    <description>Meibomian gland loss grading</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Meibomian Gland Dysfunction</condition>
  <arm_group>
    <arm_group_label>normal</arm_group_label>
    <description>no make up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eyeliner only</arm_group_label>
    <description>three days a week at least for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mascara only</arm_group_label>
    <description>three days a week at least for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eyeliner and mascara</arm_group_label>
    <description>three days a week at least for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Schirmer test</intervention_name>
    <description>Tear tests Meibomian gland grading test</description>
    <arm_group_label>eyeliner and mascara</arm_group_label>
    <arm_group_label>eyeliner only</arm_group_label>
    <arm_group_label>mascara only</arm_group_label>
    <arm_group_label>normal</arm_group_label>
    <other_name>Non contact tear break up test</other_name>
    <other_name>Meibomography</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        18 to 35 year old females with eyeliner, mascara or combined use for study groups 18 to 35&#xD;
        year old females with no make up use for control group&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To use eyeliner/mascara or combined for at least 3 days for 6 months for study groups No&#xD;
        routine eye make up use for the cıontrol group&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any systemic or ocular disease taht can affect ocular surface&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>eye make up use</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>ErolOlcok Corum WEducatin and Research Hospital</name>
      <address>
        <city>Corum</city>
        <zip>19000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zeynep E Ercan, MD</last_name>
      <phone>905322059636</phone>
      <email>zeynepeylul.ercan@saglik.gov.tr</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erol Olcok Corum Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Zeynep Eylül Ercan</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>meibomian, eyeliner</keyword>
  <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/NCT04478955
org study id: Corum State Hospital
nct id: NCT04478955
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to compare the degree of tear film instability and severity of
      meibomian gland loss between subjects who use eyeliner, mascara, a combination of both and
      those who do not use eyeliner.
observational model: Cohort
time perspective: Cross-Sectional
measure: Schirmer test
time frame: 5 minutes
description: Tear measurement
measure: Non contact tear break up test
time frame: 17 seconds
description: tear stability calculation
measure: Meibomography
time frame: 2 minutes
description: Meibomian gland loss grading
arm group label: normal
description: no make up
arm group label: eyeliner only
description: three days a week at least for 6 months
arm group label: mascara only
description: three days a week at least for 6 months
arm group label: eyeliner and mascara
description: three days a week at least for 6 months
intervention type: Diagnostic Test
intervention name: Schirmer test
description: Tear tests Meibomian gland grading test
arm group label: eyeliner and mascara
arm group label: eyeliner only
arm group label: mascara only
arm group label: normal
other name: Non contact tear break up test
other name: Meibomography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: eye make up use
minimum age: 18 Years
maximum age: 35 Years
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Erol Olcok Corum Training and Research Hospital
investigator full name: Zeynep Eylül Ercan
investigator title: Doctor
mesh term: Meibomian Gland Dysfunction