Safety and efficacy of levofloxacin 1.5% eyedrops in nonhuman primates having penetrating keratoplasty: clinical and laboratory findings.
OBJECTIVE
To determine the safety and efficacy of levofloxacin 1.5% eyedrops.


METHODS
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.


CONCLUSIONS
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.
Gramates
Peggy H
PH
Department of Ophthalmology, Tulane University, New Orleans, Louisiana, USA. phgmd@aol.com
McDonald
Marguerite B
MB
Salib
George
G
Clark
Leslie
L
D000818:Animals; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001082:Aqueous Humor / Q000378:metabolism; D001706:Biopsy; D003315:Cornea / Q000187:drug effects* / Q000378:metabolism / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015948:Keratoplasty, Penetrating; D064704:Levofloxacin; D008253:Macaca mulatta; D018613:Microscopy, Confocal; D015242:Ofloxacin / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics / Q000627:therapeutic use*; D009883:Ophthalmic Solutions; D010781:Photography; D011182:Postoperative Care; D011300:Preoperative Care
D000900:Anti-Bacterial Agents; D009883:Ophthalmic Solutions; D064704:Levofloxacin; D015242:Ofloxacin