Measuring Parkinson's Disease With Tear Fluid

Completed

• Conditions: Idiopathic Parkinson Disease

• Registration Number: NCT03037463
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-31
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• established Parkinson's Disease for at least 6 months
• Healthy controls without neurological illness

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States