Double blind, randomised, placebo controlled, crossover, multicentre studyto determine the efficacy 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 ob jective and subjective improvement in patients with dry eye syndrome. This study compared the efficacy and safety of a 0.1% solution of hyaluronan wit h 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 subje cts 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 significa nt improvements in Schirmer's score (p=0.0006) and rose bengal staining sco re (p=0.0001) were observed during treatment with hyaluronan. In a subjecti ve assessment of the effectiveness of two treatments, a majority of subject s felt that hyaluronan was more effective than saline in alleviating the sy mptoms 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. Hyaluro nan was shown to be well tolerated.