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Adv Ther. 2015 Dec;32(12):1263-79. doi: 10.1007/s12325-015-0273-6. Epub 2015 Dec 11.

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 information

1
Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.
2
North-Western State Medical University Named After I.I. Mechnikov, Saint Petersburg, Russian Federation.
3
Novosibirsk State Medical University, Novosibirsk, Russian Federation.
4
Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation.
5
Saratov State Medical University Named After V.I. Razumovsky, Saratov, Russian Federation.
6
Samara State Medical University, Samara, Russian Federation.
7
Pirogov Russian National Research Medical University, Moscow, Russian Federation.
8
The Omsk State Medical Academy, Omsk, Russian Federation.
9
The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odessa, Ukraine.
10
Kharkiv National Medical University, Kharkiv, Ukraine.
11
Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.
12
Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.
13
Moscow Helmholtz Research Institute of Eye Diseases, Moscow, Russian Federation.
14
Federal State Institution of Science Scientific Center of Biomedical Technology of the Federal Medical-Biological Agency of Russia, Svetlye Gory, Russian Federation.
15
Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation. karger@mitotech.ru.
16
Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation. karger@mitotech.ru.
17
Limited Liability Company, National Medicines Agency, Moscow, Russian Federation.
18
Federal State Budgetary Institution, Scientific Center for Expertise of Medical Application Products of the Ministry of Health, Moscow, Russian Federation.
19
Biological Faculty, Lomonosov Moscow State University, Moscow, Russian Federation.
20
Mitotech LLC, Moscow, Russian Federation.

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.

KEYWORDS:

Dry eye syndrome; Mitochondria-targeted antioxidants; Ophthalmology; SkQ1

PMID:
26660938
PMCID:
PMC4679790
DOI:
10.1007/s12325-015-0273-6
[Indexed for MEDLINE]
Free PMC Article

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