Safety and efficacy of levofloxacin 1.5% eyedrops in nonhuman primates having penetrating keratoplasty: clinical and laboratory findings.

ABSTRACT

PURPOSE: To determine the safety and efficacy of levofloxacin 1.5% eyedrops. SETTING: Tulane University Delta Research Primate Center, New Orleans, Louisiana, USA. METHODS: Ten monkeys had preoperative slitlamp examinations, photographs, and confocal microscopy. Levofloxacin 1.5% or control eyedrops were given 4 times a day in both eyes for 2 days and every 5 minutes for the hour before surgery and 4 times a day in both eyes for 1 week. Confocal microscopy, slitlamp examination, and slitlamp photography were repeated preoperatively. Intraoperative aqueous humor and corneal biopsies were taken. RESULTS: There were no differences between groups in slitlamp examinations, slitlamp photography, confocal microscopy, or histology; the mean levofloxacin level in the aqueous humor was 4.49 mug/mL +/-1.59 SD and in the corneal biopsies, 103.85 +/- 51.48 mug/g. CONCLUSION: Levofloxacin 1.5% drops given on a typical perioperative schedule to monkeys having penetrating keratoplasty showed no clinical or histological signs of toxicity and reached corneal issue levels well over the minimum inhibitory concentrations for all known ocular pathogens.