Effect of Clemastine Fumarate on Color Vision in Healthy Controls

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT02613091
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: Clemastine fumarate	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Sep 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy control

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sandler Neurosciences Building, Neurological Clinical Research Unit	San Francisco	California	United States	94107

Sponsors and Collaborators

• University of California, San Francisco

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Ari Green, MD, MCR, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02613091
• Other Study ID Numbers: Clemastine Color Vision
• First Posted: Nov 24, 2015
• Last Update Posted: Nov 3, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Ari Green, MD, MCR, University of California, San Francisco: volunteers
• Additional relevant MeSH terms: Clemastine

Study Results

No Results Posted as of Nov 3, 2016