Effect of Clemastine Fumarate on Color Vision in Healthy Controls

November 2, 2016 updated by: Ari Green, University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • Sandler Neurosciences Building, Neurological Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy control

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clemastine
This group will receive 8mg of clemastine daily.
Drug: Clemastine fumarate
4mg 2x day clemastine fumarate orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 3 day, 3 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 3 day, 3 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Ari Green, MD, MCR, UC San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

November 20, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

November 2, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clemastine Color Vision

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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