xml: <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/NCT06013436</url>
    </required_header>
    <id_info>
      <org_study_id>22LLZX10</org_study_id>
      <nct_id>NCT06013436</nct_id>
    </id_info>
    <brief_title>AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye</brief_title>
    <acronym>AST/SS</acronym>
    <official_title>Autologous Serum Tears Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With Sjögren's Syndrome Dry Eye</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chengdu University of Traditional Chinese Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chengdu University of Traditional Chinese Medicine</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 objective of the present study was to evaluate the efficacy of autologous serum tears&#xD;
        combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their&#xD;
        effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05%&#xD;
        cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in&#xD;
        patients with dry eyes related to Sjogren's syndrome.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's&#xD;
        syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to&#xD;
        evaluate their effect on corneal nerves.&#xD;
  &#xD;
        Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of&#xD;
        fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study.&#xD;
        Following a 4-week washout period, the treatment was inverted for each patient for the same&#xD;
        duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time,&#xD;
        corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy&#xD;
        were investigated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>cornea nerves</measure>
      <time_frame>12 weeks</time_frame>
      <description>cornea sub-basal nerve density</description>
    </primary_outcome>
    <primary_outcome>
      <measure>cornea staining score</measure>
      <time_frame>4 weeks</time_frame>
      <description>to evaluate corneal epithelial repair（0= no staining; 1= less than 5 staining points; 2= more than 5 and less than 30 staining points within the range of two quadrants; and 3= staining exceeding two quadrants or staining points more than 30）</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Ocular Surface Disease Index (OSDI)</measure>
      <time_frame>4 weeks</time_frame>
      <description>to assess the quality of life and clinical symptom；The survey generated a score ranging 0-100 (0 indicated absence of eye discomfort and 100 represented maximum eye discomfort)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Schirmer's test</measure>
      <time_frame>4 weeks</time_frame>
      <description>to assess tear flow</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>tear film breakup time (TBUT)</measure>
      <time_frame>4 weeks</time_frame>
      <description>to assess tear film stability</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">30</enrollment>
    <condition>Sjogren's Syndrome</condition>
    <condition>Dry Eye</condition>
    <condition>Ocular Surface Disease</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <description>Autologous serum tears, twelve times daily（per hour）, 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Autologous serum tears combined with 0.05% cyclosporin eye drop</intervention_name>
      <description>All patients administrated autologous serum tears twelve times daily（per hour） and 0.05% cyclosporin eye drop twice times daily in each eye for 12 weeks.</description>
      <arm_group_label>Experimental group</arm_group_label>
      <other_name>Ciclosporin Eye Drops(II)（Cyclone® ，SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.）</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          From June 2022 to June 2023, moderate and severe dry eye patients with Sjogren's syndrome&#xD;
          were treated in the Department of Ophthalmology and Rheumatology and Immunology of the&#xD;
          Hospital of Chengdu University of Traditional Chinese Medicine.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients were diagnosed with SS according to the classification criteria defined by&#xD;
               the American-European Consensus Group for the diagnosis of SS and also diagnosed with&#xD;
               severe DED based on the consensus of Chinese dry eye experts.&#xD;
  &#xD;
            -  Age 18-65 years old.&#xD;
  &#xD;
            -  Controlled collagen disease by the same rheumatologists at least 3 months prior to the&#xD;
               initiation of the trial.&#xD;
  &#xD;
            -  At least one eye that failed to respond to previous treatments including lartificial&#xD;
               tears, topical ocular NSAIDs or corticosteroids.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with DED related to meibomian gland dysfunction, blepharitis, abnormal&#xD;
               blinking, conjunctival relaxation or any other diseases besides SS.&#xD;
  &#xD;
            -  Diagnosed with allergic conjunctivitis, uveitis, ocular hypertension, retinopathy and&#xD;
               other eye diseases.&#xD;
  &#xD;
            -  Those who have a history of previous ocular oprations, eye injuries or contact lenses&#xD;
               usage.&#xD;
  &#xD;
            -  Known hypersensitivity to experimental drugs or any of its ingredients.&#xD;
  &#xD;
            -  Necessity to modify the systemic treatment of previous diseases during the trial.&#xD;
  &#xD;
            -  Pregnancy or lactation.&#xD;
  &#xD;
            -  Severe systemic disease.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jiachun Hu, Resident</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospital of Chengdu University of Traditional Chinese Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Hospital of Chengdu University of Traditional Chinese Medicine</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610072</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chengdu University of Traditional Chinese Medicine</investigator_affiliation>
      <investigator_full_name>Jiachun Hu</investigator_full_name>
      <investigator_title>Resident physician</investigator_title>
    </responsible_party>
    <keyword>autologous serum tears</keyword>
    <keyword>0.05% cyclosporin eye drop</keyword>
    <keyword>cornea nerves</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sjogren's Syndrome</mesh_term>
      <mesh_term>Dry Eye Syndromes</mesh_term>
      <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cyclosporine</mesh_term>
      <mesh_term>Ophthalmic Solutions</mesh_term>
      <mesh_term>Cyclosporins</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013436
  org study id: 22LLZX10
  nct id: NCT06013436
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the present study was to evaluate the efficacy of autologous serum tears
        combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their
        effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05%
        cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in
        patients with dry eyes related to Sjogren's syndrome.
  Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's
        syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to
        evaluate their effect on corneal nerves.
  
        Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of
        fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study.
        Following a 4-week washout period, the treatment was inverted for each patient for the same
        duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time,
        corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy
        were investigated.
  observational model: Case-Control
  time perspective: Prospective
  measure: cornea nerves
  time frame: 12 weeks
  description: cornea sub-basal nerve density
  measure: cornea staining score
  time frame: 4 weeks
  description: to evaluate corneal epithelial repair（0= no staining; 1= less than 5 staining points; 2= more than 5 and less than 30 staining points within the range of two quadrants; and 3= staining exceeding two quadrants or staining points more than 30）
  measure: Ocular Surface Disease Index (OSDI)
  time frame: 4 weeks
  description: to assess the quality of life and clinical symptom；The survey generated a score ranging 0-100 (0 indicated absence of eye discomfort and 100 represented maximum eye discomfort)
  measure: Schirmer's test
  time frame: 4 weeks
  description: to assess tear flow
  measure: tear film breakup time (TBUT)
  time frame: 4 weeks
  description: to assess tear film stability
  arm group label: Experimental group
  description: Autologous serum tears, twelve times daily（per hour）, 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks.
  intervention type: Drug
  intervention name: Autologous serum tears combined with 0.05% cyclosporin eye drop
  description: All patients administrated autologous serum tears twelve times daily（per hour） and 0.05% cyclosporin eye drop twice times daily in each eye for 12 weeks.
  arm group label: Experimental group
  other name: Ciclosporin Eye Drops(II)（Cyclone® ，SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.）
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Jiachun Hu, Resident
  role: Principal Investigator
  affiliation: Hospital of Chengdu University of Traditional Chinese Medicine
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Chengdu University of Traditional Chinese Medicine
  investigator full name: Jiachun Hu
  investigator title: Resident physician
  mesh term: Sjogren's Syndrome
  mesh term: Dry Eye Syndromes
  mesh term: Keratoconjunctivitis Sicca
  mesh term: Syndrome
  mesh term: Cyclosporine
  mesh term: Ophthalmic Solutions
  mesh term: Cyclosporins