Effect of Clemastine Fumarate on Color Vision in Healthy Controls

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613091
• Other study ID #: Clemastine Color Vision
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2015
• Last updated: November 2, 2016
• Start date: April 2016

Study information

• Verified date: November 2016
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy control

Exclusion Criteria:

• Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Clemastine fumarate
4mg 2x day clemastine fumarate orally.

Locations

Country	Name	City	State
United States	Sandler Neurosciences Building, Neurological Clinical Research Unit	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Laroche. Modification of color vision elicited by the use of normal therapeutical dosage of some drugs. French Annals of Pharmaceuticals. 1972.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline cone contrast test score at 3 weeks	Cone contrast and color vision testing to be performed at all 3 study visits	baseline, 3 day, 3 week	No
Secondary	Change from baseline Lanthany D15 score at 3 weeks	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	baseline, 3 day, 3 week	No