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.
OBJECTIVE
To assess the safety and performance of a 0.1% (w/v) solution of sodium hyaluronate (HA, Fermavisc, 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 and the 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 was seen 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).


CONCLUSIONS
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 shown by a reduction in the level of staining of corneal epithelial cells by rose bengal. This study confirms that Fermavisc is a safe and effective product for use in the alleviation of symptoms of severe dry eye syndrome.
Vitrolife UK Ltd, Edinburgh, UK.
C C
CC
McDonald
S B
SB
Kaye
F C
FC
Figueiredo
G
G
Macintosh
C
C
Lockett
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 / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000009:adverse effects / Q000627:therapeutic use; D011142:Polyvinyl Alcohol / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D009883:Ophthalmic Solutions; D011142:Polyvinyl Alcohol; D006820:Hyaluronic Acid