PURPOSE

To evaluate the efficacy and safety of 0.18% sodium hyaluronate ophthalmic solution (Rejena, Vismed) compared with its vehicle for the treatment of signs and symptoms of dry eye disease.

DESIGN

Randomized, placebo-controlled clinical trial.

METHODS

A total of 444 subjects with dry eye disease were randomized 1:1 to active study drug (n = 221) or vehicle control (n = 223) in this multicenter, double-masked trial. Subjects instilled 1 to 2 drops, 3 to 6 times daily for 14 days, with evaluations at Days 7 and 14. The study's 2 primary efficacy endpoints were change from baseline at Day 7 in lissamine green staining scores (objective) and in global symptom frequency scores (subjective). Results were analyzed using Wilcoxon rank sum test and Student t test in the intent-to-treat (ITT) population with last observation carried forward (LOCF).

RESULTS

At Day 7, the differences between the active and vehicle groups in change from baseline for lissamine green staining score (P = .050, Wilcoxon; P = .029, t test) and global symptom frequency score (P = .050, Wilcoxon; P = .017, t test) were both statistically significant. There were no clinically relevant safety findings related to the use of Rejena.

CONCLUSIONS

This study demonstrated the clinical efficacy of Rejena in the treatment of dry eye disease in both a primary objective endpoint and a primary subjective endpoint when compared to its vehicle. The study results also supported the well-known safety profile of Rejena.