title: Preservative-free diclofenac sodium 0.1% for vernal keratoconjunctivitis.
abstract: OBJECTIVE
  The aim of this study is to evaluate the efficacy of prolonged treatment with preservative-free diclofenac sodium 0.1% eye drops in patients with vernal keratoconjunctivitis (VKC).
  
  
  METHODS
  A prospective open study was performed in 22 patients with VKC treated with preservative-free diclofenac sodium 0.1% eye drops. Patients used the eye drops four times daily in both eyes for 120 days. Signs (papillae, hyperaemia and corneal lesions) and symptoms (itching, redness and photophobia) of the ocular surface were graded and statistically evaluated before and after treatment by a non-parametric test (Mann-Whitney U-test).
  
  
  RESULTS
  Forty per cent of the patients showed an improvement in their symptoms at the end of the treatment. Total signs and symptoms scores were significantly decreased at the end of treatment compared with the baseline values (from 6.13+/-1.45 to 0.81+/-0.90 and from 5.40+/-1.18 to 2.63+/-0.95, respectively; P<0.001). Significant decreases in conjunctival redness (P<0.001), itching (P<0.001) and photophobia (P<0.001 ) were observed at the end of treatment. Conjunctival hyperaemia was significantly reduced (P<0.001) at the end of treatment, while no significant differences were observed for corneal lesions and for papillary size. No patient showed exacerbation of the disease during the treatment.
  
  
  CONCLUSIONS
  VKC is a chronic disease that requires prolonged treatment to control the inflammatory process. Our preliminary study demonstrates the efficacy and safety of preservative-free diclofenac sodium 0.1% eye drops in controlling the signs and symptoms of VKC in prolonged treatment.
authors.affiliation: Department of Ophthalmology, University of Rome Tor Vergata, Via Moscati 31, Italy.
authors.forename: Gennaro
authors.initials: G
authors.lastname: D'Angelo
authors.forename: Alessandro
authors.initials: A
authors.lastname: Lambiase
authors.forename: Magdalena
authors.initials: M
authors.lastname: Cortes
authors.forename: Roberto
authors.initials: R
authors.lastname: Sgrulletta
authors.forename: Roberta
authors.initials: R
authors.lastname: Pasqualetti
authors.forename: Ambra
authors.initials: A
authors.lastname: Lamagna
authors.forename: Stefano
authors.initials: S
authors.lastname: Bonini
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003233:Conjunctivitis, Allergic / Q000188:drug therapy*; D004008:Diclofenac / Q000008:administration & dosage / Q000627:therapeutic use*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D011446:Prospective Studies; D012449:Safety
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D004008:Diclofenac