Authors: Patrick I Condona, Charles G McEwenb, Mark Wrightc, Graeme Mackintoshd, Robin J Prescotte, Carolyn McDonaldf

Setting:  a Ardkeen Hospital, Waterford, Ireland, b 14 Somerset Place, Glasgow, c Princess Alexandra Eye Pavilion, Edinburgh, d Gloucestershire Royal Hospital, Gloucester, e Medical Statistics Unit, University of Edinburgh Medical School, Edinburgh, f Fermentech Medical Limited, Edinburgh

Accepted for publication 18 May 1999

Journal: Br J Ophthalmol 1999;83:1121-1124 ( October )

 BACKGROUND/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.