<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/NCT03302273</url>
  </required_header>
  <id_info>
    <org_study_id>5</org_study_id>
    <nct_id>NCT03302273</nct_id>
  </id_info>
  <brief_title>Corneal Epithelial Stem Cells and Dry Eye Disease</brief_title>
  <official_title>Topical Cadaveric-Derived Corneal Epithelial Stem Cell Transplant Therapy for the Treatment of Severe Dry Eye Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sloan W. Rush, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Panhandle Eye Group, LLP</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>
      To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product&#xD;
      (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments.&#xD;
      This pilot study will carefully observe and monitor each qualifying and willing individual&#xD;
      for response to treatment, signs of toxicity and adverse effects from the treatment, and for&#xD;
      ability of the treatment to improve comfort and restore vision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients presenting with severe dry eye disease that have failed treatment with&#xD;
      conventional measures will be screened for inclusion into the study. The treatment will&#xD;
      consist of administration of formulated topical eye drops containing cadaveric epithelial&#xD;
      stem cell-derived product. These eye drops will be transplanted by topical&#xD;
      self-administration by the patient four times daily in both eyes for a three month interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">April 1, 2022</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</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>Ocular Surface Disease Index (OSDI)</measure>
    <time_frame>3 months</time_frame>
    <description>Patient Reported Outcome by Survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Acuity</measure>
    <time_frame>3 months</time_frame>
    <description>Snellen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Corneal Topography</measure>
    <time_frame>3 months</time_frame>
    <description>Automated corneal topographic indices</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Dry Eye Syndromes</condition>
  <condition>Dry Eye</condition>
  <condition>Ocular Inflammation</condition>
  <condition>Ocular Surface Disease</condition>
  <condition>Ocular Discomfort</condition>
  <condition>Blepharitis</condition>
  <arm_group>
    <arm_group_label>Corneal Epithelial Stem Cell Transplant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment will consist of transplantation (via self-administration) of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material four times daily in both eyes for a three month interval.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Corneal Epithelial Stem Cell Transplant</intervention_name>
    <description>Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.</description>
    <arm_group_label>Corneal Epithelial Stem Cell Transplant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of advanced dry eye disease&#xD;
&#xD;
          -  Severe dry eye symptoms despite having tried over a half dozen treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to undergo clinical trial&#xD;
&#xD;
          -  Unable to comply with treatment regimen&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rush Eye Associates</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Panhandle Eye Group, LLP</investigator_affiliation>
    <investigator_full_name>Sloan W. Rush, MD</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>stem cell therapy</keyword>
  <keyword>dry eye disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dry Eye Syndromes</mesh_term>
    <mesh_term>Keratoconjunctivitis Sicca</mesh_term>
    <mesh_term>Eye Diseases</mesh_term>
    <mesh_term>Blepharitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03302273
org study id: 5
nct id: NCT03302273
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To study of a novel, therapeutic Human Cells, Tissues, and Cellular and Tissue-Based Product
      (HCT/P) in the treatment of severe dry eye disease that is failing conventional treatments.
      This pilot study will carefully observe and monitor each qualifying and willing individual
      for response to treatment, signs of toxicity and adverse effects from the treatment, and for
      ability of the treatment to improve comfort and restore vision.
Eligible patients presenting with severe dry eye disease that have failed treatment with
      conventional measures will be screened for inclusion into the study. The treatment will
      consist of administration of formulated topical eye drops containing cadaveric epithelial
      stem cell-derived product. These eye drops will be transplanted by topical
      self-administration by the patient four times daily in both eyes for a three month interval.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ocular Surface Disease Index (OSDI)
time frame: 3 months
description: Patient Reported Outcome by Survey
measure: Visual Acuity
time frame: 3 months
description: Snellen
measure: Corneal Topography
time frame: 3 months
description: Automated corneal topographic indices
arm group label: Corneal Epithelial Stem Cell Transplant
arm group type: Experimental
description: The treatment will consist of transplantation (via self-administration) of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material four times daily in both eyes for a three month interval.
intervention type: Other
intervention name: Corneal Epithelial Stem Cell Transplant
description: Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.
arm group label: Corneal Epithelial Stem Cell Transplant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Panhandle Eye Group, LLP
investigator full name: Sloan W. Rush, MD
investigator title: Physician
mesh term: Dry Eye Syndromes
mesh term: Keratoconjunctivitis Sicca
mesh term: Eye Diseases
mesh term: Blepharitis
mesh term: Inflammation
sharing ipd: No