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Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery

Authors M Nardi, C Lobo, A Bereczki, J Cano, E Zagato et al

Published 15 February 2008 Volume 2007:1(4) Pages 527—533

M Nardi1, C Lobo2, A Bereczki3, J Cano4, E Zagato5, S Potts6, G Sullins6, R Notivol7, for the International C-04-65 Study Group*

1Neuroscienze-Clinica Oculistica, Università degli Studi di Pisa, Pisa, Italy; 2AIBILI, Coimbra, Portugal; 3Ophthalmology, Petz Aladár Hospital, Györ, Hungary; 4Oftalmología, Hospital Municipal, Badalona, Spain; 5Alcon Italia, Milan, Italy; 6R&D, Alcon Research Ltd., Fort Worth, TX, USA; 7Alcon Cusí, SA, Barcelona, Spain *Members of the International C-04-65 Study Group are listed in the Acknowledgments

Background: To compare nepafenac 0.1% with placebo and ketorolac 0.5% for prevention and treatment of ocular pain and inflammation after cataract surgery.

Methods: In a multi-center, randomized, placebo- and active-controlled, double-masked clinical trial, 227 patients with cataract were randomized to receive nepafenac 0.1%, ketorolac 0.5%, or placebo TID beginning 1 day pre-operatively and continuing for 21 days postoperatively. At each postoperative visit, cure rates and clinical success rates (≤5 aqueous cells and no flare) were calculated, and investigators evaluated patients’ pain. On Day 7, patients judged ocular comfort after study drug instillation.

Results: Nepafenac 0.1% produced significantly more cures compared to placebo at Day 14 (76.3% vs 59.2%, p = 0.0241), more clinical successes from Day 7 onward (p 0.05), and more pain-free patients from Day 3 onward (p 0.05). Nepafenac 0.1% was superior to ketorolac 0.5% in terms of clinical success at Day 14 (p = 0.0319) and in percentage of pain-free patients at Day 3 (p = 0.0366). Nepafenac 0.1% also demonstrated less discomfort upon instillation than ketorolac 0.5% (p = 0.0158).

Conclusion: The anti-inflammatory efficacy of nepafenac 0.1% is better than that of placebo; it is also more comfortable and at least equal to ketorolac 0.5% in the prevention and treatment of postoperative ocular pain and inflammation.

Keywords: NSAIDs, cataract, inflammation, nepafenac, ketorolac