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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: Clemastine fumarate Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2016
Actual Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Clemastine
This group will receive 8mg of clemastine daily.
 Drug: Clemastine fumarate
4mg 2x day clemastine fumarate orally.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy control

Exclusion Criteria:

  • Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613091


Locations
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United States, California
Sandler Neurosciences Building, Neurological Clinical Research Unit
San Francisco, California, United States, 94107
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Ari Green, MD, MCR UC San Francisco
More Information
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Publications:
Laroche. Modification of color vision elicited by the use of normal therapeutical dosage of some drugs. French Annals of Pharmaceuticals. 1972.

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Responsible Party: Ari Green, MD, MCR, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02613091    
Other Study ID Numbers: Clemastine Color Vision
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016
Keywords provided by Ari Green, University of California, San Francisco:
volunteers
Additional relevant MeSH terms:
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Clemastine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents