Ofloxacin (OFLX), is one of the new quinolones and is widely used in oral treatment of suppurative otitis media. To investigate the usefullness of a topical OFLX solution in the otological field, an early phase II study was performed on suppurative otitis media. At first, an 0.5% OFLX otic solution was administered to 10 healthy male volunteers, twice daily for 7 days, to check the presence of irritability or hypersensitivity. After that, the efficacy and safety of 0.1%, 0.3%, and 0.5% OFLX otic solutions were compared at 12 Japanese institutions. 1. 0.5% OFLX otic solution did not cause irritation or hypersensitivity reactions in the external auditory canal or tympanic membrane of healthy volunteers. 2. The clinical efficacy rates, judged by the doctors in charge were 71.4% (10/14), 94.4% (17/18), and 80.0% (16/20) in the 0.1%, 0.3%, and 0.5% groups, respectively. The clinical efficacy rates according to the criteria based on changes of main signs and symptoms were found to be 69.2% (9/13), 75.0% (12/16), and 77.8% (14/18), respectively. 3. The safety of OFLX otic solution was evaluated in 55 patients and no side effects were noted. Audiometry measured before and after the treatment in patients showed no significant changes in any of the cases. 4. OFLX showed strong activities against isolated organisms, including S. aureus and P. aeruginosa. The MIC₈₀ of OFLX against total isolates was 1.56μg/ml. 5. It was demonstrated that an OFLX otic solution of 0.3% concentration or greater was effective and safe against suppurative otitis media.

View full 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.

View full 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.

View full 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.

View full abstract

The efficacy and safety of an otic solution of a new quinolone derivative, ofloxacin (OFLX) was tested in children with external and middle ear inflammations. The results obtained were as follows: 1. The topical administration of 0.3% OFLX solution into the tympanic cavity was effective in 100% of the patients receiving the drug once a day, and in 86.7% of the subjects treated twice a day. 2. Clinical efficacy in patients with external otitis media was 66.7% for cases receiving the drug once a day and 100% for the ones treated twice a day. 3. Bacterial eradication was obtained in 92.9% of the cases receiving the drug once a day, and in 92.4% of the ones receiving it twice a day. 4. No adverse effects were observed in any of the patients. From these results, OFLX otic solution is a very effective and safe topical agent for treating otitis media and otitis media externa in children.

View full abstract