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A hypotonic sodium hyaluronate (SH) solution has shown significant efficacy and good tolerability for treatment of signs and symptoms of dry eye disease in a Phase III trial.
The study of 304 patients, published in J Fr Ophthalmol, shows significant superiority of 28 days’ treatment with 0.18% SH solution over saline in the primary endpoint – subjective symptom frequency score (p=0.0376).
The secondary endpoint, objective fluorescein staining score, was likewise significantly better in patients randomised to receive 0.18% SH solution than those given saline, with p=0.0074.
For the study, participants were told to use one drop of the allocated product in each eye, two-to-four times per day, for 84 days. They were assigned to receive 0.18% SH solution, saline or carbomer.
Researchers led by Vincent Baeyens from TRB Chemedica International SA in Geneva, Switzerland, said that 0.18% SH “caused a statistically significant improvement in both a subjective endpoint and an objective endpoint”.
They added: “0.18% SH was well tolerated and resulted in a low incidence of adverse events.”