title: Double blind, randomised, placebo controlled, crossover, multicentre study to determine the efficacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome.
abstract: OBJECTIVE
  Hyaluronan (sodium hyaluronate) has been shown to confer objective and subjective improvement in patients with dry eye syndrome. This study compared the efficacy and safety of a 0.1% solution of hyaluronan with 0.9% saline, when administered topically to the eye, in the treatment of symptoms of severe dry eye syndrome.
  
  
  METHODS
  A randomised, double blind, crossover clinical trial in which subjects were randomised to receive either hyaluronan or saline, applied as one or two drops to the eye, three or four times a day or as required. After 28 days' treatment, subjects crossed over to the other study medication for a further 28 days' treatment.
  
  
  RESULTS
  70 subjects were included in the analyses of efficacy and significant improvements in Schirmer's score (p=0.0006) and rose bengal staining score (p=0.0001) were observed during treatment with hyaluronan. In a subjective assessment of the effectiveness of two treatments, a majority of subjects felt that hyaluronan was more effective than saline in alleviating the symptoms of burning and grittiness (p<0.001). No adverse events attributable to hyaluronan treatment were reported.
  
  
  CONCLUSIONS
  The study demonstrates a clear benefit of hyaluronan over saline, in both subjective and objective assessments of dry eye syndrome. Hyaluronan was shown to be well tolerated.
authors.affiliation: Ardkeen Hospital, Waterford, Ireland.
authors.forename: P I
authors.initials: PI
authors.lastname: Condon
authors.forename: C G
authors.initials: CG
authors.lastname: McEwen
authors.forename: M
authors.initials: M
authors.lastname: Wright
authors.forename: G
authors.initials: G
authors.lastname: Mackintosh
authors.forename: R J
authors.initials: RJ
authors.lastname: Prescott
authors.forename: C
authors.initials: C
authors.lastname: McDonald
mesh_terms: D000328:Adult; D000368:Aged; D018592:Cross-Over Studies; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D017060:Patient Satisfaction; D012965:Sodium Chloride / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D009883:Ophthalmic Solutions; D012965:Sodium Chloride; D006820:Hyaluronic Acid