Objective
To compare the safety and efficacy of ofloxacin otic solution with those of Cortisporin otic solutions (neomycin sulfate, polymyxin B sulfate, and hydrocortisone) in otitis externa in adults and children.
Design
Two randomized, evaluator-blind, multicenter trials, 1 each in children and adults.
Setting
Twenty-three primary care and referral 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 clinically evaluable (CE), and those for 98 children and 98 adults were microbiologically evaluable (ME).
Interventions
Ofloxacin (adults, 0.5 mL; children, 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 subjects were cured if all signs and symptoms resolved at posttherapy (days 11-13) and test-of-cure (days 17-20) visits. The ME subjects had microbiological and clinical successes if they were cured and had microbiological eradication or presumed eradication.
Results
Cure was observed in 82% and 97% of CE adults and children treated with ofloxacin and 84% and 95% of CE adults and children treated with Cortisporin, respectively. The most common pathogens at the pretherapy visit were Pseudomonas aeruginosa, Staphylococcus aureus, and enteric bacilli. There were no statistically significant differences in clinical or microbiological and clinical cure or in the rates of adverse events between treatment 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.
Arch Otolaryngol Head Neck Surg. 1997;123:1193-1200
