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OpenTrials
Completed

NCT Number: NCT03037463

Measuring Parkinson's Disease With Tear Fluid

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.

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Key information

Conditions

Idiopathic Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Southern California

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Identification of Tear Biomarkers for Parkinson's Disease Patients

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 31, 2017
Registry last updated
May 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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