title: Tacrolimus vs. cyclosporine eyedrops in severe cyclosporine-resistant vernal keratoconjunctivitis: A randomized, comparative, double-blind, crossover study.
abstract: BACKGROUND
  Vernal keratoconjunctivitis (VKC) is a chronic sight-threatening ocular disease. Topical cyclosporine A (Cyc) has been widely administered as a steroid-sparing drug, although in about 7-10% of cases, it has been ineffective. The purpose of this study was to evaluate the efficacy of 0.1% topical tacrolimus (Tcr) in patients with severe VKC who failed to respond to 1% Cyc eyedrops.
  
  
  METHODS
  Consecutive patients with severe, Cyc-resistant VKC were enrolled in a double-blind, comparative, crossover (DBCO) trial; all patients were treated with 1% Cyc in one eye and 0.1% Tcr in the other eye for 3 wk. After a washout period of 7 days, patients were instructed to cross over the medications for three additional weeks. Objective ocular score, subjective score, and quality-of-life questionnaires (QoLQ) were collected during the trial. Blood samples were drawn to assess several safety parameters.
  
  
  RESULTS
  Thirty patients have been enrolled (mean age 9.05 ± 2.12 yr). In each of the two phases of the DBCO trial, a significant improvement in objective and subjective scores was observed in the eyes treated with 0.1% Tcr (p < 0.001). Likewise, the quality of life significantly improved despite only half the eyes being successfully treated. Serum creatinine and blood parameters were constantly within the normal range, and both blood Cyc and Tcr concentrations remained below the lowest detectable levels.
  
  
  CONCLUSIONS
  Topical Tcr is very effective and safe in the short term for patients suffering from severe VKC resistant to topical Cyc.
authors.affiliation: Allergy Unit, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Neri
authors.initials: N
authors.lastname: Pucci
authors.affiliation: Ophthalmology Unit, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Caputo
authors.affiliation: Allergy Unit, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: di Grande
authors.affiliation: Ophthalmology Unit, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Cinzia
authors.initials: C
authors.lastname: de Libero
authors.affiliation: Allergy Unit, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Mori
authors.affiliation: Allergy Unit, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Barni
authors.affiliation: Pharmaceutical Service, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Lorena
authors.initials: L
authors.lastname: di Simone
authors.affiliation: Pharmaceutical Service, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Calvani
authors.affiliation: Epidemiology Unit, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Franca
authors.initials: F
authors.lastname: Rusconi
authors.affiliation: Allergy Unit, A. Meyer Children's Hospital, Florence, Italy.
authors.forename: Elio
authors.initials: E
authors.lastname: Novembre
mesh_terms: D002648:Child; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D003404:Creatinine / Q000097:blood; D018592:Cross-Over Studies; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects; D018450:Disease Progression; D004311:Double-Blind Method; D004351:Drug Resistance; D005123:Eye / Q000187:drug effects*; D005260:Female; D006801:Humans; D008297:Male; D009883:Ophthalmic Solutions / Q000008:administration & dosage*; D011788:Quality of Life; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D009883:Ophthalmic Solutions; D016572:Cyclosporine; D003404:Creatinine; D016559:Tacrolimus
keywords: calcineurin inhibitors; children; vernal keratoconjunctvitis