Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis

The purpose of this study is to gather confirmatory data on the efficacy and safety of 2% miconazole oil after topical otic administration in subjects with otomycosis, and to fully establish evidence of efficacy for miconazole oil compared to the placebo (mineral oil). A 14-day regimen of twice-daily administration of 2% miconazole oil will be compared with the same treatment regimen using the placebo, mineral oil. This study is a randomized, double-blind, parallel-group study to be conducted at up to 8 study centers in the US. An estimated 90 male or female subjects with otomycosis will receive study drug. Subjects will be randomly assigned in a 1:1 ratio within study site to receive miconazole oil or mineral oil for 14 days \[administered as 5 drops per ear at \~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis\]. Both the subject and the investigator and study staff will be blinded as to the contents of the study drug. The primary efficacy endpoint is: • Clinical Cure, defined as score of 0 for fungal elements, and for each of the signs/symptoms of pruritus, aural fullness and debris, at the Test of Cure visit.