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Measuring Parkinson's Disease With Tear Fluid

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ClinicalTrials.gov Identifier: NCT03037463
Recruitment Status : Active, not recruiting
First Posted : January 31, 2017
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sarah Hamm-Alvarez, University of Southern California

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
Idiopathic Parkinson Disease

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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
Study Start Date : January 2017
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Parkinson's Disease
Control



Primary Outcome Measures :
  1. Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls [ Time Frame: up to 12 months ]
    4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The investigators will recruit participants with Parkinson's disease and controls from the Parkinson's Disease and Movement Disorder Center at the University of Southern California (USC) and from the surrounding community.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037463


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California

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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     History of Changes
Other Study ID Numbers: 11594
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases