The aim was to demonstrate the superiority of TobraDex (tobramycin 3 mg/mL, dexamethasone 1 mg/mL) eye drops over Tobrex (tobramycin 3 mg/mL)/vehicle (placebo) eye drops in the prophylaxis of inflammation after cataract surgery, and to provide addnl. safety data on TobraDex.Twenty-two ophthalmol. clinics from Brazil, Belgium, Germany, Ireland, Portugal, Spain and Sweden.Prospective, randomized, double-masked, two-arm, parallel-group, placebo-controlled, multicenter study in 417 patients undergoing extracapsular cataract extraction with intraocular lens implantation.Patients were randomized (1: 1) to TobraDex or to Tobrex/vehicle.One drop of TobraDex or Tobrex was instilled in the operative eye (four times daily) on the day before surgery (day -1), one drop immediately following surgery in the operated eye (day 0), and then treatment (four times daily) was continued until day 7 (inclusive).From day 8 through day 21, patients in the TobraDex group continued with the same treatment, but patients in the Tobrex/vehicle arm received the inactive ingredient only.Efficacy was assessed at 1, 3, 8, 14 and 21 days.The primary efficacy variable was the percentage of patients without post-surgical anterior chamber inflammation (i.e. with a sum of cells and flare scores of zero) on the day 8 visit.TobraDex was significantly better (p < 0.05) than Tobrex/vehicle in controlling post-surgical inflammation at day 8 as shown by the percentage of patients with an inflammation score of zero (51% vs 21%, resp.).The percentage of patients with treatment failure was 4% vs 16% (p < 0.001) in favor of TobraDex.In the safety population (n = 415), 19% of patients reported a total of 52 adverse events while receiving TobraDex and 35.3% patients reported 103 adverse events while receiving Tobrex/vehicle.One patient receiving Tobrex/vehicle discontinued the study due to an ocular allergic reaction.No patient experienced clin. relevant changes in visual acuity, fundus parameters, cup/disk ratio or intraocular pressure related to treatment following the day of surgery.TobraDex eye drops were superior to Tobrex/vehicle in controlling post-surgical inflammation following cataract extractionTobraDex administered four times daily over 21 days post-surgery was safe and well tolerated in patients treated for the prevention of post-surgical inflammation following cataract extraction