Effect of Clemastine Fumarate on Color Vision in Healthy Controls

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Clemastine fumarate

• Registration Number: NCT02613091
• Lead Sponsor: University of California, San Francisco

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 Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-11-20
• Study First Posted: 2015-11-24
• Study Start: 2016-04
• Primary Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Healthy control

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clemastine	Clemastine fumarate	This group will receive 8mg of clemastine daily.

Primary Outcome Measures

Name	Time	Method
Change from baseline cone contrast test score at 3 weeks	baseline, 3 day, 3 week	Cone contrast and color vision testing to be performed at all 3 study visits

Secondary Outcome Measures

Name	Time	Method
Change from baseline Lanthany D15 score at 3 weeks	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

Trial Locations

Locations (1)

Sandler Neurosciences Building, Neurological Clinical Research Unit; 🇺🇸 San Francisco, California, United States