Diclofenac-Gentamicin Combination Eye Drops Compared with Corticosteroid-Antibiotic Combination Eye Drops after Cataract Surgery

Summary

The purpose of this study was to compare the efficacy and tolerability of diclofenac-gentamicin combination eye drops with that of dexamethasoneneomycin-polymyxin B combination eye drops (Maxitrol®) in the postoperative management of patients undergoing extracapsular cataract surgery and lens implantation. This was a prospective, randomised, double-masked, parallel-group, 4-week, multicentre study with patient visits 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-gentamicin 152, Maxitrol® 152) enrolled in the study, 259 (diclofenac-gentamicin 131, Maxitrol® 128) were available for per-protocol analyses of efficacy. The two treatment groups were similar at baseline. There was no significant difference between the two treatment groups in the primary efficacy variable, the sum of grades of anterior chamber flare 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). Although possible drug-related adverse events were more frequent in the diclofenac-gentamicin group (14.9%) compared with Maxitrol® (7.5%), the difference was not statistically significant (p > 0.1), and all study patients normalised with appropriate therapy. In conclusion, diclofenac-gentamicin eye drops were as effective and well tolerated as Maxitrol® eye drops in the control of post-cataract surgery inflammation.