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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.

AbstractBACKGROUND/AIMS:
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.
CONCLUSION:
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.
AuthorsP I Condon, C G McEwen, M Wright, G Mackintosh, R J Prescott, C McDonald
JournalThe British journal of ophthalmology (Br J Ophthalmol) Vol. 83 Issue 10 Pg. 1121-4 (Oct 1999) ISSN: 0007-1161 [Print] England
PMID10502570 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Ophthalmic Solutions
  • Sodium Chloride
  • Hyaluronic Acid
Topics
  • Adult
  • Aged
  • Cross-Over Studies
  • Double-Blind Method
  • Dry Eye Syndromes (drug therapy)
  • Female
  • Humans
  • Hyaluronic Acid (therapeutic use)
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Patient Satisfaction
  • Sodium Chloride (therapeutic use)
  • Treatment Outcome

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