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

被引：66

作者：

Brzheskiy, Vladimir V. ^{[1
]}

Efimova, Elena L. ^{[1
]}

Vorontsova, Tatiana N. ^{[1
]}

Alekseev, Vladimir N. ^{[2
]}

Gusarevich, Olga G. ^{[3
]}

Shaidurova, Ksenia N. ^{[3
]}

Ryabtseva, Alla A. ^{[4
]}

Andryukhina, Olga M. ^{[4
]}

Kamenskikh, Tatiana G. ^{[5
]}

Sumarokova, Elena S. ^{[5
]}

Miljudin, Eugeny S. ^{[6
]}

Egorov, Eugeny A. ^{[7
]}

Lebedev, Oleg I. ^{[8
]}

Surov, Alexander V. ^{[8
]}

Korol, Andrii R. ^{[9
]}

Nasinnyk, Illia O. ^{[9
]}

Bezditko, Pavel A. ^{[10
]}

Muzhychuk, Olena P. ^{[10
]}

Vygodin, Vladimir A. ^{[11
,12
]}

Yani, Elena V. ^{[13
]}

Savchenko, Alla Y. ^{[14
]}

Karger, Elena M. ^{[11
,12
]}

Fedorkin, Oleg N. ^{[11
,12
]}

Mironov, Alexander N. ^{[15
]}

Ostapenko, Victoria ^{[12
,16
]}

Popeko, Natalia A. ^{[12
]}

Skulachev, Vladimir P. ^{[11
]}

Skulachev, Maxim V. ^{[12
,17
,18
]}

机构：

[1] St Petersburg State Pediat Med Univ, St Petersburg, Russia

[2] North Western State Med Univ, St Petersburg, Russia

[3] Novosibirsk State Med Univ, Novosibirsk, Russia

[4] Moscow Reg Res & Clin Inst MONIKI, Moscow, Russia

[5] Saratov State Med Univ, Saratov, Russia

[6] Samara State Med Univ, Samara, Russia

[7] Pirogov Russian Natl Res Med Univ, Moscow, Russia

[8] Omsk State Med Acad, Omsk, Russia

[9] Natl Acad Med Sci Ukraine, Filatov Inst Eye Dis & Tissue Therapy, Odessa, Ukraine

[10] Kharkiv Natl Med Univ, Kharkov, Ukraine

[11] Moscow MV Lomonosov State Univ, Belozersky Inst Physicochem Biol, Moscow, Russia

[12] Moscow MV Lomonosov State Univ, Inst Mitoengn, Moscow, Russia

[13] Moscow Helmholtz Res Inst Eye Dis, Moscow, Russia

[14] Fed Med Biol Agcy Russia, Sci Ctr Biomed Technol, Fed State Inst Sci, Svetlye Gory, Russia

[15] Natl Medicines Agcy, Ltd Liabil Co, Moscow, Russia

[16] Minist Hlth, Sci Ctr Expertise Med Applicat Prod, Fed State Budgetary Inst, Moscow, Russia

[17] Moscow MV Lomonosov State Univ, Fac Biol, Moscow, Russia

[18] Mitotech LLC, Moscow, Russia

来源：

ADVANCES IN THERAPY | 2015年 / 32卷 / 12期

关键词：

Dry eye syndrome; Mitochondria-targeted antioxidants; Ophthalmology; SkQ1; TARGETED PLASTOQUINONE DERIVATIVES; INTERRUPT EXECUTION; MITOCHONDRIA; SENESCENCE; SKQ1; ANTIOXIDANT; DIAGNOSIS; SYMPTOMS; DISEASE; TOOLS;

D O I：

10.1007/s12325-015-0273-6

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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. 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. 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. Based on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage. Mitotech LLC.

引用

页码：1263 / 1279

页数：17

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