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  • Title: Results of a Multicenter, Randomized, Double-Masked, Placebo-Controlled Clinical Study of the Efficacy and Safety of Visomitin Eye Drops in Patients with Dry Eye Syndrome.
    Author: Brzheskiy VV, Efimova EL, Vorontsova TN, Alekseev VN, Gusarevich OG, Shaidurova KN, Ryabtseva AA, Andryukhina OM, Kamenskikh TG, Sumarokova ES, Miljudin ES, Egorov EA, Lebedev OI, Surov AV, Korol AR, Nasinnyk IO, Bezditko PA, Muzhychuk OP, Vygodin VA, Yani EV, Savchenko AY, Karger EM, Fedorkin ON, Mironov AN, Ostapenko V, Popeko NA, Skulachev VP, Skulachev MV.
    Journal: Adv Ther; 2015 Dec; 32(12):1263-79. PubMed ID: 26660938.
    Abstract:
    INTRODUCTION: This article presents the results of an international, multicenter, randomized, double-masked, placebo-controlled clinical study of Visomitin (Mitotech LLC, Moscow, Russian Federation) eye drops in patients with dry eye syndrome (DES). Visomitin is the first registered (in Russia) drug with a mitochondria-targeted antioxidant (SkQ1) as the active ingredient. METHODS: In this multicenter (10 sites) study of 240 subjects with DES, study drug (Visomitin or placebo) was self-administered three times daily (TID) for 6 weeks, followed by a 6-week follow-up period. Seven in-office study visits occurred every 2 weeks during both the treatment and follow-up periods. Efficacy measures included Schirmer's test, tear break-up time, fluorescein staining, meniscus height, and visual acuity. Safety measures included adverse events, slit lamp biomicroscopy, tonometry, blood pressure, and heart rate. Tolerability was also evaluated. RESULTS: This clinical study showed the effectiveness of Visomitin eye drops in the treatment of signs and symptoms of DES compared with placebo. The study showed that a 6-week course of TID topical instillation of Visomitin significantly improved the functional state of the cornea; Visomitin increased tear film stability and reduced corneal damage. Significant reduction of dry eye symptoms (such as dryness, burning, grittiness, and blurred vision) was also observed. CONCLUSION: Based on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage. FUNDING: Mitotech LLC.
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