A randomised, crossover, multicentre study to compare the performance of 0.1% (w/v) sodium hyaluronate with 1.4% (w/v) polyvinyl alcohol in the alleviation of symptoms associated with dry eye syndrome.

Aims To assess the safety and performance of a 0.1% (w/v) solution of sodium hyaluronate (HA, Fermavisc((R)), in the alleviation of symptoms of severe dry eye in comparison with a 1.4% (w/v) solution of polyvinyl alcohol.Methods A randomised, crossover, multicentre study carried out at eight centres in the UK. Eligible patients giving written informed consent were randomised to the order in which they would receive the two study products. Each treatment period lasted for 4 weeks, then the patient crossed over to the other study product. Symptoms of burning and grittiness were assessed by visual analogue scale (VAS) at each study visit and other objective clinical assessments of ocular structure and function were carried out at baseline andthe end of each treatment period.Results Thirty-nine patients were entered into the study and 32 completed both treatment periods and were included in the statistical analyses. A significant improvement in the patients' VAS assessment of burning wasseen after treatment with HA (P = 0.03, 95% Confidence Interval: -23.5 to -1.1). This treatment also resulted in a significantly lower rose bengal staining score (P = 0.04, 95% Confidence Interval: -1.62 to -0.05 for the right eye).Conclusion The results show a significant clinical benefit in terms of relief of the symptom of burning when HA is applied topically to the eye three or four times per day or as required. HA also appears to have a protective effect on the corneal epithelium, as shownby a reduction in the level of staining of corneal epithelial cells by rose bengal. This study confirms that Fermavisc((R)) is a safe and effective product for use in the alleviation of symptoms of severe dry eye syndrome.Eye (2002) 16, 601-607. doi:10.1038/sj.eye.6700169

作 者：

McDonald CC；Kaye SB；Figueiredo FC；Macintosh G；Lockett C

刊 名：

Eye 

年，卷(期)：

2002V.16,no.5,2002("") 

分类号：

 

关键词：

symptoms <1>  w/v  therapeutic aspects  Sjogren's syndrome B antibody  Performance

正文语种：

eng 

基金项目：