A single topical agent is clinically equivalent to the combination of topical and oral antibiotic treatment for otitis externa.

Objective: To demonstrate clinical equivalence (statistical noninferiority) of topical ciprofloxacin and hydrocortisone (CHC, Cipro HC) and topical neomycin/polymyxin b/hydrocortisone (NPH, Cortisporin) with systemic amoxicillin (AMX, Amoxil), for treatment of acute otitis externa (AOE).

Design: Randomized, active-control, observer-blind, multicenter trial.

Patients: Altogether, 206 patients were enrolled (CHC, 106; NPH + AMX, 100).