This trial is active, not recruiting.

Condition healthy subjects
Treatment clemastine fumarate
Phase phase 1
Sponsor University of California, San Francisco
Start date April 2016
End date September 2016
Trial size 20 participants
Trial identifier NCT02613091, Clemastine Color Vision


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
This group will receive 8mg of clemastine daily.
clemastine fumarate
4mg 2x day clemastine fumarate orally.

Primary Outcomes

Change from baseline cone contrast test score at 3 weeks
time frame: baseline, 3 day, 3 week

Secondary Outcomes

Change from baseline Lanthany D15 score at 3 weeks
time frame: baseline, 3 day, 3 week

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - Healthy control Exclusion Criteria: - Preexisting ophthalmologic conditions such as optic neuritis, macular star, glaucoma

Additional Information

Principal investigator Ari Green, MD, MCR
Description Additional evaluation of pharmacokinetic data will be performed to confirm pharmacokinetic measures and correlate blood levels of drug to color performance if seen.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.