Double blind clinical test results of Ofloxacin otic solution for the treatment of chronic suppurative otitis media and its acute exacerbations

Abstract

In order to evaluate the clinical efficacy and safety of an 0.3% Ofloxacin (OFLX) otic solution, in treating suppurative otitis media, a double blind study was carried out in patients. The study compared the topical administration of OFLX otic solution with a placebo solution in patients with chronic suppurative otitis media, some of whom had acute exacerbations. Cephalexin was orally administered concomitantly. Clinical efficacy was analyzed in 185 patients (91 received OFLX, 94 received a placebo). One of the OFLX patients was analyzed only regarding efficacy because of an oversight by the chief physicians. As a result, his efficacy data was not included in this report. Side effects were analyzed in 204 patients (102 administered OFLX, 102 administered placebo) and clinical usefulness was analyzed in 185 patients (91 administered OFLX, 94 administered placebo). The following results were obtained: 1) The overall rate of ‘excellent’ and ‘good’, as judged by the chief physicians was 72.5% for the OFLX group and 50.5% for the placebo group. 2) The overall rate of ‘excellent’ as judged by the committee was 40.0% for the OFLX group and 22.3% for the placebo group. Both sets of results were significantly different. 3) As to improvement rate of subjective and objective symptoms, a significantly higher rate was obtained with the OFLX group than with the placebo group. 4) The bacteriological eliminatin rate of causative orgnisms in all cases was 79.7% treated with OFLX and 45.7% treated with placebo; the difference was significant. 5) Side effects were observed in 1 patient (1.0%) in the OFLX group and in 2 patients (2.0%) in the placebo group. No significant difference was observed in the incidence of adverse reactions, which were transient and not severe. 6) The overall clinical usefulness rate as judged by the chief physicians was significantly greater for the OFLX group (72.5%) than for the placebo group (48.9%). From the above results it is concluded that 0.3% OFLX otic solution possesses excellent antibacterial activity, and is an efficient and safe topical preparation for the treatment of suppurative otitis media.