Measuring Parkinson's Disease With Tear Fluid

Idiopathic Parkinson Disease Clinical Trial

Official title:

Identification of Tear Biomarkers for Parkinson's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037463
• Other study ID #: 11594
• Status: Completed
• Start date: January 2017
• Est. completion date: March 2022

Study information

• Verified date: May 2022
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls	4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits	up to 12 months