EFFICACY OF OFLOXACIN VS CEFAZOLIN AND TOBRAMYCIN IN THE THERAPY FOR BACTERIAL KERATITIS - REPORT FROM THE BACTERIAL-KERATITIS-STUDY-RESEARCH-GROUP

Purpose: To compare ofloxacin solution with a combination of fortified antibiotic cefazolin sodium and tobramycin sulfate solutions in the t reatment of bacterial keratitis. Methods: Patients under care at any o ne of 28 participating clinical centers who had an eye with suspected bacterial keratitis were randomly allocated in a double-masked manner to treatment with 0.3% ofloxacin solution or a combination of the fort ified antibiotics (1.5% tobramycin and 10.0% cefazolin solutions). Mai n Outcome Measures: Time to healing defined as complete re-epithelizat ion, accompanied by a nonprogressive stromal infiltrate for two consec utive visits. Secondary outcome measures included patient symptoms and signs of infection and adverse reactions to study medications. Only p atients with a positive bacterial corneal culture were included in mos t analyses. Results: A positive bacterial corneal culture was obtained in 140 (56%) of the 248 enrolled patients. The time to healing was si milar among the 73 patients receiving ofloxacin and the 67 patients re ceiving fortified antibiotics (P=.70). By 7 days after study entry, th e keratitis in 37% of the ofloxacin group and 38% of the fortified ant ibiotics group had healed. By 28 days, keratitis in 89% of the ofloxac in group and 86% of the fortified antibiotics group had healed. Two pa tients receiving ofloxacin and one receiving fortified antibiotics dis continued study medication because of lack of efficacy. Patients recei ving ofloxacin reported substantially less burning and stinging on ins tillation than the patients receiving fortified antibiotics (P<.001). Five of six patients among the 140 with positive bacterial cultures wh o had study medications discontinued because of ocular side effects we re in the fortified antibiotics group; an additional three patients, a ll in the fortified antibiotics group, among the remaining 108 receivi ng study medications had ocular side effects. Conclusions: The efficac y of ofloxacin solution in treating bacterial keratitis is equivalent to that of the fortified cefazolin and tobramycin solutions. The reduc ed frequency of ocular toxic effects and the relative ease of preparat ion of ofloxacin are additional considerations.