CLINICAL-TRIAL OF OTOTOPICAL OFLOXACIN FOR TREATMENT OF CHRONIC SUPPURATIVE OTITIS-MEDIA

A multicenter, open-label prospective trial was performed to determine the clinical and microbiologic efficacy of ofloxacin (OFLX) otic solu tion in the treatment of subjects greater than or equal to 12 years wi th chronic suppurative otitis media (CSOM) and a chronically perforate d tympanic membrane in the infected ear(s). A total of 207 patients at 27 centers in the United States and Central America received OFLX 0.5 mL instilled ototopically twice daily for 14 consecutive days. The pr imary clinical end point was cure (dry ear) or failure (not dry ear). The primary microbiologic end point was eradication of baseline pathog ens. Because there was no comparator and there were few data in the li terature regarding clinical efficacy in patients treated With other re gimens, the efficacy of OFLX was compared with data recorded in the cl inical records of historical-practice control (HPC) or current-practic e control (CPC) subjects. The incidence of clinical cure in clinically evaluable OFLX-treated patients (91%; 148 of 162 subjects) was signif icantly higher than in HPC subjects (67%; 124 of 185 subjects) or CPC subjects (70%; 38 of 54 subjects). OFLX eradicated all baseline pathog ens isolated in microbiologically evaluable subjects. These pathogens were predominantly Staphylococcus aureus, Pseudomonas aeruginosa, and Proteus mirabilis. The most common treatment-related adverse event, bi tter taste, occurred in 17% (35 of 207) of OFLX-treated subjects. Thus OFLX 0.5 mL administered twice daily for 14 days was effective in res olving the signs and symptoms of CSOM in subjects greater than or equa l to 12 years, was significantly more effective than therapies used to treat HPC or CPC subjects, and was well tolerated.