Effect of Clemastine Fumarate on Color Vision in Healthy Controls

• ClinicalTrials.gov Identifier: NCT02613091
• Recruitment Status: Completed
• First Posted: November 24, 2015
• Last Update Posted: November 3, 2016
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): Ari Green, University of California, San Francisco

Tracking Information

• First Submitted Date: October 23, 2015
• First Posted Date: November 24, 2015
• Last Update Posted Date: November 3, 2016
• Study Start Date: April 2016
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 20, 2015)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 20, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Clemastine Fumarate on Color Vision in Healthy Controls
• Official Title: Not Provided
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Healthy Subjects

Intervention

Drug: Clemastine fumarate

4mg 2x day clemastine fumarate orally.

Study Arms

Experimental: Clemastine

This group will receive 8mg of clemastine daily.

Intervention: Drug: Clemastine fumarate

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 2, 2016): 23
• Original Estimated Enrollment (submitted: November 20, 2015): 20
• Study Completion Date: Not Provided
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy control

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02613091
• Other Study ID Numbers: Clemastine Color Vision
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ari Green, University of California, San Francisco
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of California, San Francisco
• Verification Date: November 2016