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C. A. Kirby, The Vismed Study Group; Superiority of Vismed® (Sodium Hyaluronate Ophthalmic Solution 0.18%) Compared With Its Vehicle in the Treatment of the Signs and Symptoms of Dry Eye Disease. Invest. Ophthalmol. Vis. Sci. 2009;50(13):4648.
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Dry eye disease can affect tear production and the ocular surface, resulting in discomfort, corneal damage, and decreased vision. This Phase 3, randomized, placebo-controlled trial evaluated the efficacy and safety of a proprietary formulation of sodium hyaluronate ophthalmic solution 0.18% (Vismed®), compared with its vehicle for the treatment of signs and symptoms of dry eye disease.
444 subjects with dry eye disease received the product (n=221) or its vehicle control (n=223). Subjects instilled 1 to 2 drops of study drug into each eye 3 to 6 times daily for 14 days, with evaluations at Days 7 and 14. The study had two primary efficacy endpoints, one objective and one subjective; change from baseline at Day 7 in lissamine green staining scores and in global symptom frequency scores, respectively. Results were analyzed using Wilcoxon rank sum and student’s t-tests. Several secondary endpoints were also evaluated.
The decrease from baseline at Day 7 in lissamine green staining scores (product -1.1, vehicle -0.7) was statistically significant using the t-test (p=0.0291) and essentially significant using the Wilcoxon rank sum test (p=0.0502). A statistically significant improvement was observed at Day 7 in global symptom frequency scores (product -1.7, vehicle -1.1; p=0.0173 [t-test] and p=0.0497 [Wilcoxon]). Several secondary efficacy endpoints reached statistical significance at Days 7 and/or 14, demonstrating that the beneficial effects of the product were sustained and detectable at Day 14. There was no clinically relevant difference in safety findings related to the use of the product as compared to vehicle.
This study demonstrated the efficacy of sodium hyaluronate ophthalmic solution 0.18% (Vismed®) in the treatment of dry eye disease in both an objective and a subjective endpoint as compared to its vehicle. Achieving significance in both endpoints has historically been a challenge for new drugs in the treatment of dry eye disease. These results provide robust evidence of the efficacy and safety of the product for the treatment of the signs and symptoms of dry eye disease.
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