Comparative dose-finding study of Ofloxacin otic solution in suppurative otitis media

Abstract

0.3% and 0.5% Ofloxacin otic solutions were topically administered to 170 patients with acute and chronic suppurative otits media, to determine the optimal dose. The efficacy rates of the 0.3% and 0.5% solutions, as judged by the physicians in charge were 85.9% (95% confidence interval; 75.6%-93.0%) and 89.7% (80.8%-95.5%), respectively. The difference between the two groups was not significant. The responce rates of all patients, as judged by both the physicians in charge and the committee, were similar, regardless of diagnostic category, strain of causative organism, severity or pattern (mono or polymicrobial) of infection, or solution concentration used. The elimination rates of causative organisms for both groups were 84.2% (72.1%-92.5%) and 80.0% (68.2%-88.9%), respectively. The only adverse reaction noted was one case of transient otalgia in each group. The usefulness rates, judged by the physicians in charge, were 84.7% (74.3-92.1%) and 89.7% (80.8-95.5%), respectively. No significant differences were observed. In conclusion, topical application of Ofloxacin in suppurative otitis media was judged to be highly useful, and that the 0.3% solution is sufficient to achieve this.