Purpose: To evaluate the levels of ofloxacin (Ocuflox(R)) in human cor
neal tissue in patients exposed to various dosing regimens and applica
tion methods. Setting: Corneal Consultants of Indiana, Indianapolis, I
ndiana, USA. Methods: Forty patients meeting inclusion criteria were r
ecruited from persons scheduled to have penetrating keratoplasty (PKP)
. Patients were placed into one of two study groups of 20 each based o
n dosing regimen and application method. The SAS GLM (General Linear M
odels) procedure was used to test for differences in mean Ocuflox tiss
ue concentration among study groups and for interaction effects of pre
operative diagnosis, trephine size, dosing regimen, and corneal integr
ity. Results: Corneal tissue concentrations of Ocuflox were elevated s
ignificantly by varying drug application methods and dosing schedules
before PKP. Eyes receiving medication every 15 minutes for 4 hours had
significantly higher levels of Ocuflox than those receiving the drug
in six doses over 24 hours before surgery. Ocuflox concentrations exce
eded the MIC90 (minimum inhibitory concentration) for key ocular patho
gens in essentially all cornea specimens studied. Conclusion: Ocuflox
penetration was improved by administering it in a controlled setting a
t 15 minute intervals over 4 hours. The drug provided high tissue leve
ls in both the cornea and aqueous humor, which together with its broad
range of antibacterial coverage, should make it a good choice for pro
phylactic treatment.