April 2009
Volume 50, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2009
Results of a Multi-centered, Randomized, Double-blind Crossover Study of the Safety and Efficacy of Topical Cyclosporine a Treatment in Vernal Keratoconjunctivitis
Author Affiliations & Notes
  • A. Lambiase
    Ophthalmology, Univ of Rome Campus Bio-Medico, Rome, Italy
  • A. Leonardi
    Ophthalmology, Univ of Padua, Padua, Italy
  • M. Sacchetti
    Ophthalmology, Univ of Rome Campus Bio-Medico, Rome, Italy
  • V. Deligianni
    Ophthalmology, Univ of Padua, Padua, Italy
  • L. Mastrella
    Ophthalmology, Univ of Rome Campus Bio-Medico, Rome, Italy
  • S. Sposato
    Ophthalmology, Univ of Rome Campus Bio-Medico, Rome, Italy
  • S. Bonini
    Ophthalmology, Univ of Rome Campus Bio-Medico, Rome, Italy
  • Footnotes
    Commercial Relationships  A. Lambiase, None; A. Leonardi, None; M. Sacchetti, None; V. Deligianni, None; L. Mastrella, None; S. Sposato, None; S. Bonini, None.
  • Footnotes
    Support  AIFA (Italian Drug Agency) Grant FARM5YZTZW
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 6326. doi:
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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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : 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).

Methods: : 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.

Results: : 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).

Clinical Trial: : www.clinicaltrials.gov NCT00426023

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • conjunctivitis • inflammation 
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