OFLOXACIN OTIC SOLUTION FOR TREATMENT OF OTITIS-EXTERNA IN CHILDREN AND ADULTS

Objective: To compare the safety and efficacy of ofloxacin otic soluti on with those of Cortisporin otic solutions (neomycin sulfate, polymyx in B sulfate, and hydrocortisone) in otitis externa in adults and chil dren. Design: Two randomized, evaluator-blind, multicenter trials, 1 e ach in children and adults. Setting: Twenty-three primary care and ref erral ambulatory care sites per trial. Patients: A total of 314 adults (12 years and older) and 287 children (younger than 12 years). Of the total, data for 247 adults and 227 children were considered clinicall y evaluable (CE), and those for 98 children and 98 adults were microbi ologically evaluable (ME). Interventions: Ofloxacin (adults, 0.5 mL; c hildren, 0.25 mL) twice daily or Cortisporin (adults, 0.2 mL; children , 0.15 mL) 4 times daily for 10 days. Main Outcome Measures: The CE su bjects were cured if all signs and symptoms resolved at posttherapy (d ays 11-13) and test-of-cure (days 17-20) visits. The ME subjects had m icrobiological and clinical successes if they were cured and had micro biological eradication or presumed eradication. Results: Cure was obse rved in 82% and 97% of CE adults and children treated with ofloxacin a nd 84% and 95% of CE adults and children treated with Cortisporin, res pectively. The most common pathogens at the pretherapy visit were Pseu domonas aeruginosa, Staphylococcus aureus, and enteric bacilli. There were no statistically significant differences in clinical or microbiol ogical and clinical cure or in the rates of adverse events between tre atment groups. Conclusions: Ofloxacin given twice daily is as safe and effective as Cortisporin given 4 times daily for otitis externa. The bacteriological findings and treatment responses do not differ between adults and children.