<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/NCT04441528</url>
  </required_header>
  <id_info>
    <org_study_id>IRB2021</org_study_id>
    <nct_id>NCT04441528</nct_id>
  </id_info>
  <brief_title>Lid Wipes Versus Baby Shampoo in Patients With Seborrehic Blepharitis</brief_title>
  <official_title>Randomized Double-Blind Trial of Lid Wipes Containing Terpinen-4-ol and Sodium Hyaluronate Versus Baby Shampoo in Patients With Seborrheic Blepharitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University - Cerrahpasa (IUC)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Koç University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul University - Cerrahpasa (IUC)</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 purpose of this study is to investigate the efficacy of lid wipes containing&#xD;
      terpinen-4-ol and sodium hyaluronate (Hy-ter®) for the treatment of seborrheic blepharitis&#xD;
      compared to baby shampoo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After being informed about the study and potential risks, all patients giving written consent&#xD;
      will have a complete ophthalmological examination to determine eligibilty for study entry. At&#xD;
      week 0, patients who meet the eligibility requirements will be randomized in a double blind&#xD;
      manner (participant and investigator) in a 1:1 ratio to lid wipes containing terpinen-4-ol&#xD;
      and sodium hyaluronate (Hy-ter®) or baby shampoo (twice daily).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>BLISS score is calculated according to the answers given to the questionnaire. Higher BLISS scores is related to a worse outcome. (Range is between 0 and 39)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>The number of mites in the epilated 4 eyelashes will be counted under microscope.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the treatment assessed by the change in the Schirmer test results</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Dry eye evaluation will be made with Schirmer test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the treatment assessed by the change in the tear breakup time</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Dry eye evaluation will be made with tear breakup time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the treatment assessed by the change in the ocular surface disease index score</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>OSDI scores are calculated according to the responses to the questionnaire. Higher values are related to a worse outcome (range is between 0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the treatment assessed by the change in the non-invasive tear breakup time</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Dry eye evaluation will be made with non-invasive tear breakup time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of the treatment assessed by the change in the meibomian gland loss</measure>
    <time_frame>0-4-8-12 weeks</time_frame>
    <description>Meibomian gland loss will be evaluated using anterior segment analysis system.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Seborrheic Blepharitis</condition>
  <arm_group>
    <arm_group_label>Lid wipes containing terpinen-4-ol and sodium hyaluronate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The lid wipes will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baby shampoo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lid wipes containing terpinen-4-ol and sodium hyaluronate</intervention_name>
    <description>Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.</description>
    <arm_group_label>Lid wipes containing terpinen-4-ol and sodium hyaluronate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baby shampoo</intervention_name>
    <description>Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.</description>
    <arm_group_label>Baby shampoo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of seborrheic blepharitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ophthalmological pathologies that may affect the tear film functions&#xD;
             including ocular rosacea, contact lens use, history of any ocular surgery, or patients&#xD;
             with systemic pathologies or those using systemic medications that may affect the tear&#xD;
             film functions&#xD;
&#xD;
          -  Patients younger than 18-year-old&#xD;
&#xD;
          -  Patients who used any treatment for blepharitis within the 6 months prior to the&#xD;
             examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul University-Cerrahpasa</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
    <investigator_full_name>Ceyhun Arici, MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>seborrheic blepharitis</keyword>
  <keyword>terpinen-4-ol</keyword>
  <keyword>baby shampoo</keyword>
  <keyword>lid wipes</keyword>
  <keyword>sodium hyaluronate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Blepharitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyaluronic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04441528
org study id: IRB2021
nct id: NCT04441528
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the efficacy of lid wipes containing
      terpinen-4-ol and sodium hyaluronate (Hy-ter®) for the treatment of seborrheic blepharitis
      compared to baby shampoo.
After being informed about the study and potential risks, all patients giving written consent
      will have a complete ophthalmological examination to determine eligibilty for study entry. At
      week 0, patients who meet the eligibility requirements will be randomized in a double blind
      manner (participant and investigator) in a 1:1 ratio to lid wipes containing terpinen-4-ol
      and sodium hyaluronate (Hy-ter®) or baby shampoo (twice daily).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy of the treatment assessed by the change in Blepharitis Symptom measure (BLISS) score
time frame: 0-4-8-12 weeks
description: BLISS score is calculated according to the answers given to the questionnaire. Higher BLISS scores is related to a worse outcome. (Range is between 0 and 39)
measure: Efficacy of the treatment assessed by the change in Demodex mite count by light microscopy
time frame: 0-4-8-12 weeks
description: The number of mites in the epilated 4 eyelashes will be counted under microscope.
measure: Efficacy of the treatment assessed by the change in the Schirmer test results
time frame: 0-4-8-12 weeks
description: Dry eye evaluation will be made with Schirmer test.
measure: Efficacy of the treatment assessed by the change in the tear breakup time
time frame: 0-4-8-12 weeks
description: Dry eye evaluation will be made with tear breakup time.
measure: Efficacy of the treatment assessed by the change in the ocular surface disease index score
time frame: 0-4-8-12 weeks
description: OSDI scores are calculated according to the responses to the questionnaire. Higher values are related to a worse outcome (range is between 0-100)
measure: Efficacy of the treatment assessed by the change in the non-invasive tear breakup time
time frame: 0-4-8-12 weeks
description: Dry eye evaluation will be made with non-invasive tear breakup time.
measure: Efficacy of the treatment assessed by the change in the meibomian gland loss
time frame: 0-4-8-12 weeks
description: Meibomian gland loss will be evaluated using anterior segment analysis system.
arm group label: Lid wipes containing terpinen-4-ol and sodium hyaluronate
arm group type: Experimental
description: The lid wipes will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
arm group label: Baby shampoo
arm group type: Active Comparator
description: Baby shampoo will be applied on the eyelids twice a day for 8 weeks followed by a discontinuation period of 4 weeks.
intervention type: Drug
intervention name: Lid wipes containing terpinen-4-ol and sodium hyaluronate
description: Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
arm group label: Lid wipes containing terpinen-4-ol and sodium hyaluronate
intervention type: Drug
intervention name: Baby shampoo
description: Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
arm group label: Baby shampoo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University - Cerrahpasa (IUC)
investigator full name: Ceyhun Arici, MD
investigator title: Associate Professor
mesh term: Blepharitis
mesh term: Hyaluronic Acid
sharing ipd: Undecided