Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)

Inclusion Criteria: Randomized blinded initial phase of study: * Male or non-pregnant, non-lactating females with a clinical diagnosis of uncomplicated otomycosis of the external ear only, * Intact tympanic membrane in the ear(s) to be treated with study drug, * In general good health as determined by medical examination and medical history, * Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study. Open-label second phase of study: * Male or non-pregnant, non-lactating females with an intact tympanic membrane in the ear(s) to be treated with study drug, * In general good health as determined by medical examination and medical history, * Free of clinically significant disease, including diabetes mellitus, that is not well-controlled or that could interfere with the study. Exclusion Criteria:: * Presence of dermatoses or conditions of the ear that may interfere with evaluation of otomycosis or with safety evaluations, including concomitant otic infections that require antimicrobial treatment, * Disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s); * Tympanostomy tube or perforated tympanic membrane; * History of prior surgery directly affecting and compromising the external auditory canal and/or tympanic membrane, except for prior tympanostomy tube(s) that have already been removed and completely healed; * Use of any topical medicated treatme…