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M. Nardi, I. Cunliffe, J. Cano, B. Cochener, R. Notivol, T. Wiernas; Nepafenac 0.1% Compared to Ketorolac 0.5% and Placebo in Cataract Surgery. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5438.
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To evaluate the efficacy and safety of nepafenac (NEP) 0.1% suspension compared to placebo (PBO) and ketorolac tromethamine (KET) 0.5% solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL implantation.
Multi-center, double-masked, placebo- and active-controlled, randomized, parallel-group trial.
Two-hundred twenty-seven patients at 15 European sites, 42 to 90 years of age, of any race and either sex, scheduled for cataract extraction with implantation of a posterior chamber intraocular lens were randomized to NEP or KET or PBO (nepafenac vehicle). The surgical eye was treated with the randomized product 1 drop TID beginning 1 day prior to surgery, continued on the day of surgery and for the first 21 days of the postoperative period. Visits were scheduled on the post-operative days 1, 3, 7, 14, 21 and 28. Primary efficacy was percent of patients cured where cure was defined as absence of cells and flare at Day 14 and at all subsequent study visits. Patients were considered a clinical success if they had less than 5 cells and no flare at a visit and at all subsequent study visits. Safety assessments included BCVA (logMAR), IOP, slit-lamp assessment, dilated fundus assessment, drop comfort assessment, and adverse events.
All 227 patients were included in the safety analysis (77 NEP, 73 KET, and 77 PBO), of which 225 qualified for intent-to-treat analysis. Overall, NEP was safe, well-tolerated and had significantly higher cure rate at Day 14 compared to PBO; significantly higher clinical success rate compared to both KET (Day 14) and PBO (Day 7 and at all subsequent visits); significantly greater percentage of pain-free patients compared to both KET (Day 3) and PBO (Day 3 and at all subsequent visits); and superior drop comfort upon instillation compared to KET.
NEP is equal to or better than KET and superior to PBO for the prevention and treatment of ocular inflammation and pain associated with cataract surgery, and NEP is more comfortable upon instillation than KET.
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