Measuring Parkinson's Disease With Tear Fluid

NCT ID: NCT03037463

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-03-31

Brief Summary

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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

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Conditions

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Idiopathic Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Parkinson's Disease

No interventions assigned to this group

Control

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Sarah Hamm-Alvarez

Professor and Vice Chair, Basic Research; Associate Dean, Basic and Translational Research; Director, Research development

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Hamm-Alvarez SF, Janga SR, Edman MC, Feigenbaum D, Freire D, Mack WJ, Okamoto CT, Lew MF. Levels of oligomeric alpha-Synuclein in reflex tears distinguish Parkinson's disease patients from healthy controls. Biomark Med. 2019 Dec;13(17):1447-1457. doi: 10.2217/bmm-2019-0315. Epub 2019 Sep 25.

Reference Type DERIVED
PMID: 31552762 (View on PubMed)

Other Identifiers

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11594

Identifier Type: -

Identifier Source: org_study_id

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