Efficacy of 0.18% hypotonic sodium hyaluronate ophthalmic solution in the treatment of signs and symptoms of dry eye disease.

BACKGROUND/AIMS: To compare the safety and efficacy of hypotonic 0.18% sodium hyaluronate solution (0.18% SH) versus saline and versus 0.3% carbomer for the treatment of signs and symptoms of moderate dry eye syndrome.

METHODS

A total of 304 patients were randomized (1:1:1) in this parallel-group, multi-center, phase III trial. They were instructed to instill one drop of the allocated product in each eye two to four times per day over 84 days. The primary efficacy criterion was the change from baseline at Day 28 in symptom frequency score. The superiority of 0.18% SH (Vismed(®)) over saline and its non-inferiority versus carbomer were statistically tested.

RESULTS

At Day 28, there was a statistically significant superiority of 0.18% SH over saline in change from baseline for subjective symptom frequency score (P=0.0376, primary endpoint) and objective fluorescein staining score (P=0.0074, secondary endpoint). 0.18% SH had an excellent safety profile over 84 days. A strong trend was observed in favour of 0.18% SH to cause less blurred vision than carbomer throughout the trial (P=0.0798 at Day 28).

CONCLUSION

0.18% SH caused a statistically significant improvement in both a subjective endpoint (symptom frequency score) and an objective endpoint (fluorescein staining score). 0.18% SH was well tolerated and resulted in low incidence of adverse events.