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.
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.
Condon
P I
PI
Ardkeen Hospital, Waterford, Ireland.
McEwen
C G
CG
Wright
M
M
Mackintosh
G
G
Prescott
R J
RJ
McDonald
C
C
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
D009883:Ophthalmic Solutions; D012965:Sodium Chloride; D006820:Hyaluronic Acid