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PURPOSE: To compare the efficacy of two formulations of prednisolone acetate 1% in reducing postoperative inflammation in patients having primary phacoemulsification surgery with IOL implantation. METHODS: This multicenter study was conducted in randomized, double-masked fashion with a parallel active control group. Patients undergoing phacoemulsification surgery with IOL implantation were assigned to one of two treatment groups receiving study drug in addition to standard therapy. Study drug was administered four times daily beginning one day before surgery, postoperatively for 14 days, then twice daily until the bottle was empty. Clinical efficacy was compared for differences in corneal surface keratitis, anterior chamber cells and flare, and postoperative pain. Results were compared on day 1, 2 weeks, and 4 weeks postoperatively. RESULTS: No statistical differences in clinical efficacy or safety were seen between the two formulations tested at any time point evaluated. CONCLUSIONS: In this study of routine cataract patients, both prednisolone acetate 1% formulations are comparably effective and safe when administered for the reduction of inflammation after phacoemulsification surgery with IOL implantation. [ABSTRACT FROM AUTHOR]