Fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution for inflammation after cataract surgery: a randomized, comparative, active treatment-controlled trial.

ABSTRACT

PURPOSE: To assess the efficacy, tolerance, and ocular tolerability of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution compared with 0.1% diclofenac (Voltaren) and 0.3% tobramycin (Tobrex) in patients undergoing cataract extraction by either nuclear expression (extracapsular) or ultrasound-assisted aspiration (phacoemulsification) with intraocular lens implantation. METHODS: Eighty-eight patients undergoing cataract extraction with intraocular lens implantation participated in a randomized, parallel, observer-masked trial, in which the clinical usefulness of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution, two eyedrops every 6 hours (n = 44) was compared with Voltaren and Tobrex, one drop of each every 6 hours (n = 44) in a 22-day course. Efficacy was assessed from changes of the sum of anterior chamber cell count plus flare, conjunctival hyperemia and edema, and ciliary congestion, by means of slit lamp biomicroscopy on days 1, 7, 14, and 21. Tolerance and ocular tolerability were assessed by recording intraocular pressure (IOP), side effects, and the patient's and investigator's opinions. RESULTS: Anterior chamber cell count plus flare showed no differences in the two treatment groups at any evaluation point. The study treatment was associated with a significantly higher score for conjunctival edema on day 1 (p = 0.015), conjuncitval hyperemia on day 14 (p = 0.009) and anterior chamber cell count on day 21 (p = 0.04), but these differences had no clinical relevance. No side effects related to the study treatment were recorded. CONCLUSIONS: Efficacy, tolerance, and ocular tolerability of a fixed-dose combination of 0.1% diclofenac plus 0.3% tobramycin ophthalmic solution were comparable to Voltaren plus Tobrex for the control of anterior chamber inflammation after cataract surgery, with the advantage that both active principles are supplied in a single container.