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Measuring Parkinson's Disease With Tear Fluid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 12, 2017
First Posted Date January 31, 2017
Last Update Posted Date May 8, 2019
Study Start Date January 2017
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2017)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03037463 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measuring Parkinson's Disease With Tear Fluid
Official Title Identification of Tear Biomarkers for Parkinson's Disease Patients
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Idiopathic Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts
  • Parkinson's Disease
  • Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 6, 2019)
205
Original Estimated Enrollment
 (submitted: January 27, 2017)
130
Estimated Study Completion Date April 2023
Estimated Primary Completion Date January 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03037463
Other Study ID Numbers 11594
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sarah Hamm-Alvarez, University of Southern California
Study Sponsor University of Southern California
Collaborators Not Provided
Investigators Not Provided
PRS Account University of Southern California
Verification Date May 2019