Am J Ophthalmol. 2010 Apr;149(4):594-601.
Vogel R, Crockett RS, Oden N, Laliberte TW, Molina L; Sodium Hyaluronate Ophthalmic Solution Study Group.
Rx Development Resources, LLC, Tampa, Florida, USA.
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
No comments:
Post a Comment