DICLOFENAC-GENTAMICIN COMBINATION EYE DROPS COMPARED WITH CORTICOSTEROID-ANTIBIOTIC COMBINATION EYE DROPS AFTER CATARACT-SURGERY

The purpose of this study was to compare the efficacy and tolerability of diclofenac-gentamicin combination eye drops with that of dexametha sone-neomycin-polymyxin B combination eye drops (Maxitrol(R)) in the p ostoperative management of patients undergoing extracapsular cataract surgery and lens implantation. This was a prospective, randomised, dou ble-masked, parallel-group, 4-week, multicentre study with patient vis its preoperatively, on the day of surgery and postoperatively on days 1, 5 to 8, 12 to 16, and 26 to 32. Of the 304 patients (diclofenac-gen tamicin 152, Maxitrol(R) 152) enrolled in the study, 259 (diclofenac-g entamicin 131, Maxitrol(R) 128) were available for per-protocol analys es of efficacy. The two treatment groups were similar at baseline. The re was no significant difference between the two treatment groups in t he primary efficacy variable, the sum of grades of anterior chamber fl are and cells, at any study visit (p = 0.91 on day 1, p = 0.12 on days 5 to 8, p = 0.28 on days 12 to 16 and p = 0.35 on days 26 to 32). Alt hough possible drug-related adverse events were more frequent in the d iclofenac-gentamicin group (14.9%) compared with Maxitrol(R) (7.5%), t he difference was not statistically significant (p > 0.1), and all stu dy patients normalised with appropriate therapy. In conclusion, diclof enac-gentamicin eye drops were as effective and well tolerated as Maxi trol(R) eye drops in the control of post-cataract surgery inflammation .