title: Efficacy and safety of cyclosporine eyedrops in vernal keratoconjunctivitis.
abstract: BACKGROUND
  Corticosteroids have been the only effective topically administered treatment for severe vernal keratoconjunctivitis (VKC), but their prolonged use is often associated with complications. Topical cyclosporine therapy has been used in the past decade, but few controlled trials have been conducted, and conflicting results have been reported.
  
  
  OBJECTIVE
  This study sought to evaluate the efficacy and safety of ocular administration of cyclosporine in VKC.
  
  
  METHODS
  Twenty-four children with severe VKC were treated with cyclosporine 2% eyedrops. The treatment began in spring and lasted 4 months. One eye was treated with cyclosporine (Cs-eye); the fellow eye received the vehicle as placebo (Pl-Cs-eye) during the first 2 weeks in a double-blind, placebo-controlled trial and thereafter was treated with cyclosporine (open trial). Patients were instructed to protect their eyes against sunlight. Ocular symptoms and signs were scored at entry and at 2 weeks, 4 weeks, and 4 months after the beginning of treatment. All children underwent biochemical and immunologic evaluations.
  
  
  RESULTS
  Compared with baseline, scores for ocular signs and symptoms at 2 weeks decreased significantly in the Cs-eyes (P < 0.001), and signs improved in the Pl-Cs-eyes (P = 0.001). A significant difference was noted between Cs-eyes and Pl-Cs-eyes at 2 weeks for both subjective (P < 0.005) and objective (P < 0.001) scores. At 4 weeks, scores for signs (P < 0.001) and symptoms (P = 0.01) were reduced in the Pl-Cs-eyes, with no further improvement in the Cs-eyes. At 4 months, clinical scores had declined further, and serum eosinophil cationic protein levels were significantly lower than at entry (P = 0.009). Most patients reported mild burning sensation and tearing after administration of cyclosporine. Four patients (17%) required an additional brief period of topical corticosteroid therapy.
  
  
  CONCLUSIONS
  Cyclosporine eyedrops were effective and safe for treating severe VKC, without causing major side effects. Most of the therapeutic effect was achieved after 2 weeks. The initial therapeutic effect was maintained during the next 3 months, with a further slow decrease in the symptoms.
authors.affiliation: Anna Meyer Children's Hospital, Department of Pediatrics, University of Florence, Italy. n.pucci@meyer.it
authors.forename: Neri
authors.initials: N
authors.lastname: Pucci
authors.forename: Elio
authors.initials: E
authors.lastname: Novembre
authors.forename: Antonella
authors.initials: A
authors.lastname: Cianferoni
authors.forename: Enrico
authors.initials: E
authors.lastname: Lombardi
authors.forename: Roberto
authors.initials: R
authors.lastname: Bernardini
authors.forename: Roberto
authors.initials: R
authors.lastname: Caputo
authors.forename: Luciana
authors.initials: L
authors.lastname: Campa
authors.forename: Alberto
authors.initials: A
authors.lastname: Vierucci
mesh_terms: D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D016572:Cyclosporine / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009883:Ophthalmic Solutions; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine