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

• Published in: British journal of ophthalmology Vol. 83; no. 10; pp. 1121 - 1124
• Main Authors: Condon, Patrick I, McEwen, Charles G, Wright, Mark, Mackintosh, Graeme, Prescott, Robin J, McDonald, Carolyn
• Format: Journal Article
• Language: English
• Published: BMA House, Tavistock Square, London, WC1H 9JR BMJ Publishing Group Ltd 01.10.1999; BMJ; BMJ Publishing Group LTD
• Subjects: Adult; Aged; Biological and medical sciences; Cell adhesion & migration; clinical trial; Cross-Over Studies; Double-Blind Method; dry eye; Dry Eye Syndromes - drug therapy; Eye; Female; Humans; Hyaluronan; Hyaluronic Acid - therapeutic use; Male; Medical sciences; Middle Aged; Molecular weight; Ophthalmic Solutions; Original articles - Clinical science; Patient Satisfaction; Patients; Pharmacology. Drug treatments; Preferences; Sodium; Sodium Chloride - therapeutic use; Studies; Treatment Outcome; Edinburgh Scotland; Human; Sodium Compounds; Dry eye syndrome; Local administration; Eye disease; Chemotherapy; Ophthalmic preparation; Randomization; Treatment; Multicenter study; Organic salt; Double blind study
• ISSN: 0007-1161; 1468-2079
• DOI: 10.1136/bjo.83.10.1121

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.