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. Issue 10 (1st October 1999)

• Record Type: Journal Article
• Authors: Condon, Patrick I; McEwen, Charles G; Wright, Mark; Mackintosh, Graeme; Prescott, Robin J; McDonald, Carolyn
• Is Part Of: British journal of ophthalmology. Volume 83:Issue 10(1999)
• Page Start: 1121
• Page End: 1124
• Publication Date: 1999-10-01
• Subjects: Hyaluronan -- dry eye -- clinical trial; Ophthalmology -- Periodicals; 617.7
• DOI: 10.1136/bjo.83.10.1121
• Languages: English
• ISSNs: 0007-1161

Abstract

Abstract : 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.