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Effect of Clemastine Fumarate on Color Vision in Healthy Controls

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ClinicalTrials.gov Identifier: NCT02613091
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Ari Green, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 23, 2015
First Posted Date  ICMJE November 24, 2015
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE April 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2015)
Change from baseline cone contrast test score at 3 weeks [ Time Frame: baseline, 3 day, 3 week ]
Cone contrast and color vision testing to be performed at all 3 study visits
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2015)
Change from baseline Lanthany D15 score at 3 weeks [ Time Frame: baseline, 3 day, 3 week ]
Lanthany D15 test to be administered at all 3 study visits. Score determined by number of "crossings" as outlined in the following link http://www.richmondproducts.com/files/8113/1550/0538/FR_15_Farnsworth_and_LanthonyD15_Instructions_Rev_1.7_0506.pdf
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Clemastine Fumarate on Color Vision in Healthy Controls
Official Title  ICMJE Not Provided
Brief Summary In a1972 study in the French Annals of Pharmaceuticals, Laroche and Laroche reported that the drug clemastine has a negative effect on patients' color discrimination, which is the ability to distinguish different hues and arrange them in the correct order. In an upcoming clinical trial studying the effect of clemastine on vision outcomes, our lab aims to assess color visual performance adding assessment of color defectiveness as a clinical endpoint. Color defectiveness is the ability to see certain colors, and is commonly referred to as color-blindness. Color discrimination and defectiveness can be related, but do not always correlate. This study aims to detect the effect, if any, that clemastine has on color defectiveness in healthy controls, which could confound its use as an outcome endpoint in future clinical trials relating to clemastine.
Detailed Description Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Healthy Subjects
Intervention  ICMJE Drug: Clemastine fumarate
4mg 2x day clemastine fumarate orally.
Study Arms  ICMJE Experimental: Clemastine
This group will receive 8mg of clemastine daily.
Intervention: Drug: Clemastine fumarate
Publications * Laroche. Modification of color vision elicited by the use of normal therapeutical dosage of some drugs. French Annals of Pharmaceuticals. 1972.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
23
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2015)
20
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy control

Exclusion Criteria:

  • Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02613091
Other Study ID Numbers  ICMJE Clemastine Color Vision
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ari Green, University of California, San Francisco
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ari Green, MD, MCR UC San Francisco
PRS Account University of California, San Francisco
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP