Efficacy and tolerability of a gatifloxacin/prednisolone acetate fixed combination for topical prophylaxis and control of inflammation in phacoemulsification: a 20-day-double-blind comparison to its individual components

ABSTRACT

OBJECTIVE: To compare the efficacy and tolerability of a fixed combination of 0.3% gatifloxacin and 1% prednisolone (Zypred®) versus the individual components used separately (Zypred® and Predfort®) for infection prophylaxis and inflammation control after cataract surgery with intraocular lens implantation. METHODS: A prospective, randomized, double-blind, parallel-group study of 108 patients who underwent phacoemulsification and intraocular lens implantation was conducted. After random assignment, 47 eyes received the fixed combination of topical 0.3% gatifloxacin/1% prednisolone drops, and 61 eyes received the same doses of the individual components as separate solutions four times a day for 15 days. Baseline and postoperative assessments were made on postoperative days 1, 7, 15, and 20. RESULTS: All objective (best corrected visual acuity, sign of active ocular inflammation, central and incisional corneal edema, the number of cells per high-power field in the anterior chamber, and intraocular pressure) and subjective (eye pain, photophobia, burning sensation, itching, and foreign body sensation) criteria of efficacy were similar in both groups, with no significant differences. Group I included 47 eyes that received the fixed combination of gatifloxacin/prednisolone acetate eye drops and a placebo eye drop solution. Group II included 61 eyes that were treated with 0.3% gatifloxacin and 1% prednisolone acetate eye drops separately. The intraocular pressure was slightly higher in Group II (p<0.05). CONCLUSION: Treatment with the fixed-dose combination of gatifloxacin/prednisolone eye drops was as effective as the non-fixed combination in preventing infection and controlling inflammation after phacoemulsification and intraocular lens implantation. .