Skip to main content
OpenTrials
Completed

NCT Number: NCT02613091

Effect of Clemastine Fumarate on Color Vision in Healthy Controls

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sandler Neurosciences Building, Neurological Clinical Research Unit

San Francisco, California, 94107, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy control

Exclusion criteria

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

Treatment and study plan

Clemastine Fumarate

Drug

4mg 2x day clemastine fumarate orally.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
First posted
Nov 24, 2015
Registry last updated
Nov 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.