Prophylactic effectiveness of tobramycin-dexamethasone eye drops compared with tobramycin/vehicle eye drops in controlling post-surgical inflammation in cataract patients : prospective, randomised, double-masked, two-arm, parallel-group, placebo-controlled, multicentre study.

OBJECTIVE: To demonstrate the superiority of TobraDex((R)) (tobramycin 3 mg/mL, dexamethasone 1 mg/mL) eye drops over Tobrex((R)) (tobramycin 3 mg/mL)/vehicle (placebo) eye drops in the prophylaxis of inflammation after cataract surgery, and to provide additional safety data on TobraDex((R)).

SETTING: Twenty-two ophthalmology clinics from Brazil, Belgium, Germany, Ireland, Portugal, Spain and Sweden.

PATIENTS AND METHODS: Prospective, randomised, double-masked, two-arm, parallel-group, placebo-controlled, multicentre study in 417 patients undergoing extracapsular cataract extraction with intraocular lens implantation. Patients were randomised (1 : 1) to TobraDex((R)) or to Tobrex((R))/vehicle. One drop of TobraDex((R)) or Tobrex((R)) 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((R)) group continued with the same treatment, but patients in the Tobrex((R))/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.

RESULTS: TobraDex((R)) was significantly better (p < 0.05) than Tobrex((R))/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%, respectively). The percentage of patients with treatment failure was 4% vs 16% (p < 0.001) in favour of TobraDex((R)). In the safety population (n = 415), 19% of patients reported a total of 52 adverse events while receiving TobraDex((R)) and 35.3% patients reported 103 adverse events while receiving Tobrex((R))/vehicle. One patient receiving Tobrex((R))/vehicle discontinued the study due to an ocular allergic reaction. No patient experienced clinically relevant changes in visual acuity, fundus parameters, cup/disc ratio or intraocular pressure related to treatment following the day of surgery.

CONCLUSIONS: TobraDex((R)) eye drops were superior to Tobrex((R))/vehicle in controlling post-surgical inflammation following cataract extraction. TobraDex((R)) 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.