Evidence map›Paper›PMID 26660938›Full record

Trial reportAdvances in therapy2015

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.

Vladimir V Brzheskiy, Elena L Efimova, Tatiana N Vorontsova, Vladimir N Alekseev, Olga G Gusarevich, Ksenia N Shaidurova, Alla A Ryabtseva, Olga M Andryukhina, Tatiana G Kamenskikh, Elena S Sumarokova and 18 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. [In vitro and in vivo antibacterial effects of the mitochondrial antioxidant Visomitin againstZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2026
    Article
  5. PMAntioxidants (Basel, Switzerland) · 2026
    Article
  6. Review
  7. Review
  8. Review
  9. Review
  10. The Multifaceted Role of Mitochondria in Angiogenesis.International journal of molecular sciences · 2025
    Review
  11. Review
  12. Review
  13. PMToxicology and applied pharmacology · 2024
    Article
  14. Review
  15. Potential New Target for Dry Eye Disease-Oxidative Stress.Antioxidants (Basel, Switzerland) · 2024
    Review
  16. Article
  17. Article
  18. Review
  19. Dietary Alcohol Consumption Elicits Corneal Toxicity Through the Generation of Cellular Oxidative Stress.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2023
    Article
  20. Expected and Unexpected Effects of Pharmacological Antioxidants.International journal of molecular sciences · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

28 authors.

Vladimir V BrzheskiySaint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.
Elena L EfimovaSaint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.
Tatiana N VorontsovaSaint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.
Vladimir N AlekseevNorth-Western State Medical University Named After I.I. Mechnikov, Saint Petersburg, Russian Federation.
Olga G GusarevichNovosibirsk State Medical University, Novosibirsk, Russian Federation.
Ksenia N ShaidurovaNovosibirsk State Medical University, Novosibirsk, Russian Federation.
Alla A RyabtsevaMoscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation.
Olga M AndryukhinaMoscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation.
Tatiana G KamenskikhSaratov State Medical University Named After V.I. Razumovsky, Saratov, Russian Federation.
Elena S SumarokovaSaratov State Medical University Named After V.I. Razumovsky, Saratov, Russian Federation.
Eugeny S MiljudinSamara State Medical University, Samara, Russian Federation.
Eugeny A EgorovPirogov Russian National Research Medical University, Moscow, Russian Federation.
Oleg I LebedevThe Omsk State Medical Academy, Omsk, Russian Federation.
Alexander V SurovThe Omsk State Medical Academy, Omsk, Russian Federation.
Andrii R KorolThe Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odessa, Ukraine.
Illia O NasinnykThe Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odessa, Ukraine.
Pavel A BezditkoKharkiv National Medical University, Kharkiv, Ukraine.
Olena P MuzhychukKharkiv National Medical University, Kharkiv, Ukraine.
Vladimir A VygodinBelozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.
Elena V YaniMoscow Helmholtz Research Institute of Eye Diseases, Moscow, Russian Federation.
Alla Y SavchenkoFederal State Institution of Science Scientific Center of Biomedical Technology of the Federal Medical-Biological Agency of Russia, Svetlye Gory, Russian Federation.
Elena M KargerBelozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation. karger@mitotech.ru.
Oleg N FedorkinBelozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.
Alexander N MironovLimited Liability Company, National Medicines Agency, Moscow, Russian Federation.
Victoria OstapenkoInstitute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.
Natalia A PopekoInstitute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.
Vladimir P SkulachevBelozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.
Maxim V SkulachevInstitute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis 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.

methodsIn 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.

resultsThis 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.

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

fundingMitotech LLC.

Indexed as

AdultBenzalkonium CompoundsCorneaDouble-Blind MethodDrug CombinationsDry Eye SyndromesFemaleFluoresceinHumansMaleMethylcelluloseMiddle AgedOphthalmic SolutionsPlastoquinoneTearsTreatment OutcomeBenzalkonium CompoundsDrug CombinationsFluoresceinMethylcelluloseOphthalmic SolutionsPlastoquinoneVisomitinDry eye syndromeMitochondria-targeted antioxidantsOphthalmologySkQ1

Identifiers

PMID26660938
PMCPMC4679790

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.