Effect of Clemastine Fumarate on Color Vision in Healthy Controls

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02613091

Enrollment

Registered

2015-11-24

Start date

2016-04-30

Completion date

Unknown

Last updated

2016-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

volunteers

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.

Interventions

DRUGClemastine fumarate

4mg 2x day clemastine fumarate orally.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy control

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026