RESUMO
PURPOSE: To demonstrate non-inferiority of eberconazole 1% otic solution to clotrimazole 1% solution, and to compare their safety profiles in the treatment of otomycosis. MATERIALS AND METHODS: Multicenter, randomized, double-blind, active treatment-controlled phase 3 clinical trial. One hundred and ninety patients with diagnosis of otomycosis were randomly assigned to eberconazole 1% otic solution or clotrimazole 1% solution. RESULTS: Baseline characteristics were comparable between both groups for age, gender, ethnicity, and clinical variables. Both study groups had high complete response rates: 81.8% in the eberconazole group and 83.5% in the clotrimazole group. Although non-inferiority of eberconazole relative to clotrimazole could not be demonstrated, a post-hoc sensitivity analysis demonstrated that eberconazole 1% otic solution was not inferior to clotrimazole 1% solution for the primary efficacy endpoint. Secondary endpoints also demonstrated that eberconazole 1% and clotrimazole 1% solutions were therapeutically similar at the end of the study. The incidence of adverse events was similar in both groups, and none had related AEs and withdrawals due to an AE. CONCLUSIONS: Eberconazole 1% otic solution is an efficacious and safe option to treat otomycosis-affected patients in the general practice.
