<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/NCT03839069</url>
  </required_header>
  <id_info>
    <org_study_id>201503027DINB</org_study_id>
    <nct_id>NCT03839069</nct_id>
  </id_info>
  <brief_title>Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis</brief_title>
  <official_title>The Effects of Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective study that aimed to observe the therapeutic effects of minor salivary&#xD;
      gland transplantation for cicatrizing conjunctivitis patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cicatrizing conjunctivitis can be the common presentation of many ocular surface diseases as&#xD;
      Stevens-Johnson syndrome (SJS), mucous membrane pemphigoid (MMP), chemical burn, Sjogren&#xD;
      syndrome, chronic graft-versus-host disease (GVHD) and ocular trauma. Ocular dryness in&#xD;
      combination with symblepharon and corneal opacity in these patients could lead to the poor&#xD;
      visual and life quality, and less favorable prognosis of ocular reconstruction.&#xD;
&#xD;
      This study aims to prospectively evaluate the therapeutic effects of minor salivary gland&#xD;
      transplantation for cicatrizing conjunctivitis. The investigators evaluate the saliva-tear&#xD;
      productivity (functional outcome) and the survival of graft (anatomical outcome) every three&#xD;
      months. The investigators would also validate whether minor salivary gland transplantation is&#xD;
      beneficial for the participant prior to further ocular reconstruction as limbal&#xD;
      transplantation and corneal grafting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">December 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 change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation</measure>
    <time_frame>the Schirmer's test will be performed every three months until 12 months after operation</time_frame>
    <description>to compare the Schirmer's test between baseline and 12 months after operation. The higher Schirmer's test results, the better tear secretion function.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation</measure>
    <time_frame>the OSDI will be monitored every three months until 12 months</time_frame>
    <description>to compare the OSDI between baseline and 12 months after operation. The higher the OSDI value, the worse of subjective ocular surface disease related symptoms.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation</measure>
    <time_frame>the COCS will be monitored every three months until 12 months after operation</time_frame>
    <description>to compare the COCS between baseline and 12 months after operation. The higher the COCS scores, the more ocular surface complications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation</measure>
    <time_frame>the impression cytology will be performed every three months until 12 months after operation</time_frame>
    <description>to compare the scores of conjunctival impression cytology between baseline and 12 months after operation. The higher the conjunctival impression cytology scores, the worse squamous metaplasia of the ocular surface.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cicatrizing Conjunctivitis</condition>
  <condition>Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum</condition>
  <condition>Sjogren Syndrome</condition>
  <condition>Mucous Membrane Pemphigoid</condition>
  <condition>Chronic Graft Versus Host Disease</condition>
  <condition>Chemical Burn to Eye</condition>
  <arm_group>
    <arm_group_label>Minor Salivary Gland Transplantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>minor salivary gland transplantation</intervention_name>
    <description>The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.</description>
    <arm_group_label>Minor Salivary Gland Transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 20-85 years old&#xD;
&#xD;
          -  unilateral or bilateral cicatrizing conjunctivitis&#xD;
&#xD;
          -  severe aqueous deficiency dry eye ( Schirmer I test result of less than 2mm)&#xD;
&#xD;
          -  chronic ocular surface disease score (COCS) over 3 points&#xD;
&#xD;
          -  Oxford scheme over grade III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active ocular infection&#xD;
&#xD;
          -  active corneal melting&#xD;
&#xD;
          -  severe xerostomia (modified Schirmer I test result of less than 25mm)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsiao-Sang Chu, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Ophthalmology, NTUH</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hsiao-Sang Chu, MD, MS</last_name>
    <phone>+886-2-23123456</phone>
    <phone_ext>63804</phone_ext>
    <email>stephaniechu@ntuh.gov.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Ophthalmology, National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hsiao Sang Chu, MD,MS</last_name>
      <phone>+886-2-23123456</phone>
      <phone_ext>63804</phone_ext>
      <email>stephaniechu@ntuh.gov.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 31, 2016</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 10, 2019</last_update_submitted>
  <last_update_submitted_qc>February 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Stevens-Johnson Syndrome</mesh_term>
    <mesh_term>Bronchiolitis Obliterans Syndrome</mesh_term>
    <mesh_term>Conjunctivitis</mesh_term>
    <mesh_term>Pemphigoid, Benign Mucous Membrane</mesh_term>
    <mesh_term>Pemphigoid, Bullous</mesh_term>
    <mesh_term>Graft vs Host Disease</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Burns, Chemical</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>for research purpose only</ipd_description>
  </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/NCT03839069
org study id: 201503027DINB
nct id: NCT03839069
lead sponsor: 
has dmc: No
This is a prospective study that aimed to observe the therapeutic effects of minor salivary
      gland transplantation for cicatrizing conjunctivitis patients.
Cicatrizing conjunctivitis can be the common presentation of many ocular surface diseases as
      Stevens-Johnson syndrome (SJS), mucous membrane pemphigoid (MMP), chemical burn, Sjogren
      syndrome, chronic graft-versus-host disease (GVHD) and ocular trauma. Ocular dryness in
      combination with symblepharon and corneal opacity in these patients could lead to the poor
      visual and life quality, and less favorable prognosis of ocular reconstruction.

      This study aims to prospectively evaluate the therapeutic effects of minor salivary gland
      transplantation for cicatrizing conjunctivitis. The investigators evaluate the saliva-tear
      productivity (functional outcome) and the survival of graft (anatomical outcome) every three
      months. The investigators would also validate whether minor salivary gland transplantation is
      beneficial for the participant prior to further ocular reconstruction as limbal
      transplantation and corneal grafting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the change of Schirmer's test result (basic tear secretion in mm) from baseline to 12 months after operation
time frame: the Schirmer's test will be performed every three months until 12 months after operation
description: to compare the Schirmer's test between baseline and 12 months after operation. The higher Schirmer's test results, the better tear secretion function.
measure: the change of ocular surface disease index (OSDI) ( ranged from 0-100) from baseline to 12 months after operation
time frame: the OSDI will be monitored every three months until 12 months
description: to compare the OSDI between baseline and 12 months after operation. The higher the OSDI value, the worse of subjective ocular surface disease related symptoms.
measure: the change of chronic ocular complication score (COCS) ( ranged from 0-12) from baseline to 12 months after operation
time frame: the COCS will be monitored every three months until 12 months after operation
description: to compare the COCS between baseline and 12 months after operation. The higher the COCS scores, the more ocular surface complications.
measure: the change of conjunctival impression cytology scores (ranged from 0-5) from baseline to 12 months after operation
time frame: the impression cytology will be performed every three months until 12 months after operation
description: to compare the scores of conjunctival impression cytology between baseline and 12 months after operation. The higher the conjunctival impression cytology scores, the worse squamous metaplasia of the ocular surface.
arm group label: Minor Salivary Gland Transplantation
arm group type: Experimental
description: Cicatrizing conjunctivitis patients that received minor salivary gland transplantation for dry eye treatment.
intervention type: Procedure
intervention name: minor salivary gland transplantation
description: The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.
arm group label: Minor Salivary Gland Transplantation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 85 Years
healthy volunteers: No
last name: Hsiao-Sang Chu, MD, MS
role: Principal Investigator
affiliation: Department of Ophthalmology, NTUH
last name: Hsiao-Sang Chu, MD, MS
phone: +886-2-23123456
phone ext: 63804
email: stephaniechu@ntuh.gov.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Stevens-Johnson Syndrome
mesh term: Bronchiolitis Obliterans Syndrome
mesh term: Conjunctivitis
mesh term: Pemphigoid, Benign Mucous Membrane
mesh term: Pemphigoid, Bullous
mesh term: Graft vs Host Disease
mesh term: Syndrome
mesh term: Burns, Chemical
sharing ipd: No
ipd description: for research purpose only