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A. Lambiase, A. Leonardi, M. Sacchetti, V. Deligianni, L. Mastrella, S. Sposato, S. Bonini; Results of a Multi-centered, Randomized, Double-blind Crossover Study of the Safety and Efficacy of Topical Cyclosporine a Treatment in Vernal Keratoconjunctivitis. Invest. Ophthalmol. Vis. Sci. 2009;50(13):6326.
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to evaluate the efficacy of topical ocular treatment with cyclosporine A (CsA) 0.05% versus ketotifen fumarate (KF) 0.025% for prevention of vernal keratoconjunctivitis (VKC) relapses in a multi-centered, randomized, double-blind, cross-over study (www.clinicaltrial.gov, ID: NCT00426023).
thirty-four asymptomatic VKC patients (28M and 6 F, 6-33 years old) with history of disease recrudescences were randomized to receive CsA (NOVA 22007®, Novagali Pharma) or ketotifen (Zaditen®, Novartis) twice daily for 6 months during spring-summer season followed by a cross-over treatment in the second year. Signs, symptoms and quality of life (QUICK test©) of patients were evaluated at baseline and after 1, 3, 6 months. Primary outcome was the different number of VKC relapses between groups. Intention to treat statistical analysis was performed by linear regression analysis.
Twenty-five patients completed the study; 9 patients were discontinued for adverse events (n=1, CsA group), missing follow-up visit (n=1, CsA) or inefficacy of treatment (n=1, CsA and n=6, ketotifen). Disease relapse occurred in 32% of patients treated with CsA versus 55% of patients treated with ketotifen. A significant reduction in the number of relapses was noted with CsA (15 relapses, mean 0.5±0.9) versus ketotifen (34 relapses, mean 1±1.1) treatment (p = 0.023).
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