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Double blind, randomised, placebo controlled, crossover, multicentre study to determine the e Y cacy of a 0.1% (w/v) sodium hyaluronate solution (Fermavisc) in the treatment of dry eye syndrome

Background/aims —Hyaluronan (sodium hyaluronate) has been shown to confer objective and subjective improvement in patients with dry eye syndrome. This study compared the e Y cacy 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 hyaluro- nan 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 e Y cacy and signiﬁcant im-provements in Schirmer’s score (p=0.0006) and rose bengal staining score (p=0.0001) were observed during treatment with hy- aluronan. In a subjective assessment of the e V ectiveness of two treatments, a majority of subjects felt that hyaluronan was more e V ective 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. ( :1121–1124)