<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/NCT03037463</url>
  </required_header>
  <id_info>
    <org_study_id>11594</org_study_id>
    <nct_id>NCT03037463</nct_id>
  </id_info>
  <brief_title>Measuring Parkinson's Disease With Tear Fluid</brief_title>
  <official_title>Identification of Tear Biomarkers for Parkinson's Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess whether tear secretion in patients with Parkinson's&#xD;
      disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that&#xD;
      will be reflected in changes in the protein composition of tear fluid, which can be measured&#xD;
      relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected&#xD;
      from Parkinson's patients, and through biochemical assays, the profile of proteins in tears&#xD;
      will be characterized and compared to that from control subjects. The profiles will be&#xD;
      analyzed with respect to any differences between Parkinson's patients and control subjects.&#xD;
      If differences appear, the levels of these potential biomarkers in Parkinson's patients will&#xD;
      be compared to the severity of their disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">March 2022</completion_date>
  <primary_completion_date type="Actual">March 2022</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>Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls</measure>
    <time_frame>up to 12 months</time_frame>
    <description>4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">205</enrollment>
  <condition>Idiopathic Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Parkinson's Disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will recruit participants with Parkinson's disease and controls from the&#xD;
        Parkinson's Disease and Movement Disorder Center at the University of Southern California&#xD;
        (USC) and from the surrounding community.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  established Parkinson's Disease for at least 6 months&#xD;
&#xD;
          -  Healthy controls without neurological illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently taking anti-cholinergic medication&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  have an exposure to neuroleptic medications other than Quetiapine or Clozapine in the&#xD;
             6 months prior to screening&#xD;
&#xD;
          -  have an active eye infection or have had eye surgery within 3 months prior to&#xD;
             screening&#xD;
&#xD;
          -  control subjects will be excluded if they have a history of neurological disease&#xD;
&#xD;
          -  PD subjects will be excluded if they have an atypical Parkinsonian syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Sarah Hamm-Alvarez</investigator_full_name>
    <investigator_title>Professor and Vice Chair, Basic Research; Associate Dean, Basic and Translational Research; Director, Research development</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</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/NCT03037463
org study id: 11594
nct id: NCT03037463
lead sponsor: 
The purpose of this study is to assess whether tear secretion in patients with Parkinson's
      disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that
      will be reflected in changes in the protein composition of tear fluid, which can be measured
      relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected
      from Parkinson's patients, and through biochemical assays, the profile of proteins in tears
      will be characterized and compared to that from control subjects. The profiles will be
      analyzed with respect to any differences between Parkinson's patients and control subjects.
      If differences appear, the levels of these potential biomarkers in Parkinson's patients will
      be compared to the severity of their disease.
observational model: Case-Control
time perspective: Prospective
measure: Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls
time frame: up to 12 months
description: 4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits
arm group label: Parkinson's Disease
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Sarah Hamm-Alvarez
investigator title: Professor and Vice Chair, Basic Research; Associate Dean, Basic and Translational Research; Director, Research development
mesh term: Parkinson Disease