Human Factors Evaluation of Labeling for Wearers of Soft Contact Lenses. Volume 5

摘要

Due to the high incidence of health problems among soft contact lens users, FDAhired a human factors research corporation, the Pacific Science and Engineering Group (PSE), to perform a laboratory investigation of user compliance with lens care instructions. The goal was to achieve a better understanding of the effects of user instructions on lens cleaning performance and to derive guidelines for preparing such instructions. At first, a team of human factors psychologists (assisted by an optometrist and an ophthalmologist) obtained baseline data from experienced wearers cleaning their lenses using manufacturers' booklets. Then, PSE prepared two prototype booklets and tested them against the best of the manufacturers' booklets (the 'best' booklet was selected on the basis of ratings by both lens wearing subjects and the research team). PSE also designed an Abbreviated booklet with warnings in the front of the booklet, separated from the procedures. A summary flow chart of project activities is shown.