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Measuring Parkinson's Disease With Tear Fluid

Sponsor
University of Southern California (Other)
Overall Status
Completed
CT.gov ID
NCT03037463
Collaborator
(none)
205
Enrollment
1
Location
61.9
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    205 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Identification of Tear Biomarkers for Parkinson's Disease Patients
    Actual Study Start Date :
    Jan 1, 2017
    Actual Primary Completion Date :
    Mar 1, 2022
    Actual Study Completion Date :
    Mar 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Parkinson's Disease
    Control

    Outcome Measures

    Primary Outcome Measures

    1. Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls [up to 12 months]

      4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • established Parkinson's Disease for at least 6 months

    • Healthy controls without neurological illness

    Exclusion Criteria:

    • currently taking anti-cholinergic medication

    • dementia

    • have an exposure to neuroleptic medications other than Quetiapine or Clozapine in the 6 months prior to screening

    • have an active eye infection or have had eye surgery within 3 months prior to screening

    • control subjects will be excluded if they have a history of neurological disease

    • PD subjects will be excluded if they have an atypical Parkinsonian syndrome

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Southern California Los Angeles California United States 90033

    Sponsors and Collaborators

    • University of Southern California

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sarah Hamm-Alvarez, Professor and Vice Chair, Basic Research; Associate Dean, Basic and Translational Research; Director, Research development, University of Southern California
    ClinicalTrials.gov Identifier:
    NCT03037463
    Other Study ID Numbers:
    • 11594
    First Posted:
    Jan 31, 2017
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of May 9, 2022