A clinical study of Ofloxacin otic solution on purulent otitis media and otitis externa in children

Abstract

An open, comparative study was made of the efficacy and safety in children of an 0.3% Ofloxacin otic solution (OFLX) applied once or twice daily to treat purulent otitis media and otitis externa. 1) Clinical effects were judged by the physicians in charge for a total of 41 cases. The overall rate of “excellent” was 65.0% and 66.7% for once and twice daily administrations, respectively, and the overall rate of “excellent” and “good” was 95.0% and 95.2%. 2. No side effects were seen in any of the cases (45 cases) evaluated. As in the case of adults, the otic solution was judged to be very safe in children. 3. Serum levels of OFLX after topical administration in children were below 0.013μg/ml, i. e. 1/100 of the level of the oral administration.