0.3-PERCENT CIPROFLOXACIN OPHTHALMIC OINTMENT IN THE TREATMENT OF BACTERIAL KERATITIS

Objective: To determine the efficacy and safety of topical 0.3% ciprof loxacin hydrochloride ophthalmic ointment in the treatment of bacteria l keratitis. Design: Prospective case series with a nonrandomized comp arison of culture-positive, evaluable cases (ciprofloxacin ointment gr oup) with culture-positive, concurrent patients (nonenrolled group) tr eated with conventional therapy. Setting: Multicenter clinical study. Patients: After informed consent was obtained, 253 eligible patients u nderwent corneal scrapings and received topical ciprofloxacin ointment ; 145 (57%) had positive. cultures and completed the follow-up schedul e. Forty (70%) of 57 apparently eligible patients had culture-positive bacterial keratitis but were not enrolled in the ciprofloxacin ointme nt study during the same period. Intervention : Ciprofloxacin ophthalm ic ointment instilled every 1 to 2 hours for 2 days, then every 4 hour s for 12 days. Main Outcome Measures: Clinical evaluation of signs at 1, 3, 7, and 14 days of treatment and the overall condition classified as clinical success (cured or improved) or failure (unchanged or wors e) during and after therapy. Results: Clinical success with the initia l treatment occurred in 135 patients (93%) in the ciprofloxacin ointme nt group and in 28 patients (70%) in the nonenrolled group. Of the 10 ciprofloxacin clinical failures, seven were staphylococcal; two, pneum ococcal, and one, polybacterial. The 90% minimum inhibitory concentrat ion of ciprofloxacin was 3 mg/L or less for corneal bacterial isolates . No serious adverse event attributable to ciprofloxacin ointment occu rred, although 32 (13%) of 253 patients developed a transient white cr ystalline corneal precipitate shown with liquid chromatography in two cases to be ciprofloxacin. Conclusion: Ciprofloxacin ophthalmic ointme nt is an effective and safe topical antimicrobial agent for the treatm ent of bacterial keratitis caused by susceptible micro organisms.