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.

Autor: Brzheskiy VV; Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation., Efimova EL; Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation., Vorontsova TN; Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation., Alekseev VN; North-Western State Medical University Named After I.I. Mechnikov, Saint Petersburg, Russian Federation., Gusarevich OG; Novosibirsk State Medical University, Novosibirsk, Russian Federation., Shaidurova KN; Novosibirsk State Medical University, Novosibirsk, Russian Federation., Ryabtseva AA; Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation., Andryukhina OM; Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation., Kamenskikh TG; Saratov State Medical University Named After V.I. Razumovsky, Saratov, Russian Federation., Sumarokova ES; Saratov State Medical University Named After V.I. Razumovsky, Saratov, Russian Federation., Miljudin ES; Samara State Medical University, Samara, Russian Federation., Egorov EA; Pirogov Russian National Research Medical University, Moscow, Russian Federation., Lebedev OI; The Omsk State Medical Academy, Omsk, Russian Federation., Surov AV; The Omsk State Medical Academy, Omsk, Russian Federation., Korol AR; The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odessa, Ukraine., Nasinnyk IO; The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odessa, Ukraine., Bezditko PA; Kharkiv National Medical University, Kharkiv, Ukraine., Muzhychuk OP; Kharkiv National Medical University, Kharkiv, Ukraine., Vygodin VA; Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.; Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation., Yani EV; Moscow Helmholtz Research Institute of Eye Diseases, Moscow, Russian Federation., Savchenko AY; Federal State Institution of Science Scientific Center of Biomedical Technology of the Federal Medical-Biological Agency of Russia, Svetlye Gory, Russian Federation., Karger EM; Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation. karger@mitotech.ru.; Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation. karger@mitotech.ru., Fedorkin ON; Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.; Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation., Mironov AN; Limited Liability Company, National Medicines Agency, Moscow, Russian Federation., Ostapenko V; Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.; Federal State Budgetary Institution, Scientific Center for Expertise of Medical Application Products of the Ministry of Health, Moscow, Russian Federation., Popeko NA; Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation., Skulachev VP; Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation., Skulachev MV; Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.; Biological Faculty, Lomonosov Moscow State University, Moscow, Russian Federation.; Mitotech LLC, Moscow, Russian Federation.
Jazyk: angličtina
Zdroj: Advances in therapy [Adv Ther] 2015 Dec; Vol. 32 (12), pp. 1263-79. Date of Electronic Publication: 2015 Dec 11.
DOI: 10.1007/s12325-015-0273-6
Abstrakt: 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.
Databáze: MEDLINE
Externí odkaz: