A Phase III Study of an Otic Formulation in Acute Otitis Externa

Inclusion Criteria: * Clinical diagnosis of AOE based on clinical observation and of presumed bacterial origin * A minimum combined score of ≥4 in at least 1 affected ear at the Day 1 exam for tenderness, erythema, and edema * Other protocol-defined inclusion criteria may apply Exclusion Criteria: * Duration of pretherapy signs or symptoms of AOE greater than four (4) weeks * Presence of a tympanostomy tube or perforated tympanic membrane in the treated ear(s). Patients with a history of tympanic membrane perforation should not be enrolled unless the absence of a current perforation can be confirmed at Visit 1 prior to enrollment * Clinically diagnosed chronic suppurative otitis media, acute otitis media, acute otorrhea in patients with tympanostomy tubes, or malignant otitis externa * Known or suspected ear infection of fungal or mycobacterial origin * Prior otologic surgery within 6 months of study entry * Seborrheic dermatitis or other skin conditions of the external auditory canal * Current or prior history of an immunosuppressive disorder (e.g., HIV positive) or current immunosuppressive therapy (e.g., cancer chemotherapy) or known acute or chronic renal disorders or active hepatitis * Diabetic patients (controlled or uncontrolled) based upon assessment by Investigator * Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study \[e.g., cleft palate (including repairs), Downs Syndrom…