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.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  Based on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage.
  
  
  BACKGROUND
  Mitotech LLC.
authors.affiliation: Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.
authors.forename: Vladimir V
authors.initials: VV
authors.lastname: Brzheskiy
authors.affiliation: Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.
authors.forename: Elena L
authors.initials: EL
authors.lastname: Efimova
authors.affiliation: Saint-Petersburg State Pediatric Medical University, Saint Petersburg, Russian Federation.
authors.forename: Tatiana N
authors.initials: TN
authors.lastname: Vorontsova
authors.affiliation: North-Western State Medical University Named After I.I. Mechnikov, Saint Petersburg, Russian Federation.
authors.forename: Vladimir N
authors.initials: VN
authors.lastname: Alekseev
authors.affiliation: Novosibirsk State Medical University, Novosibirsk, Russian Federation.
authors.forename: Olga G
authors.initials: OG
authors.lastname: Gusarevich
authors.affiliation: Novosibirsk State Medical University, Novosibirsk, Russian Federation.
authors.forename: Ksenia N
authors.initials: KN
authors.lastname: Shaidurova
authors.affiliation: Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation.
authors.forename: Alla A
authors.initials: AA
authors.lastname: Ryabtseva
authors.affiliation: Moscow Regional Research and Clinical Institute (MONIKI), Moscow, Russian Federation.
authors.forename: Olga M
authors.initials: OM
authors.lastname: Andryukhina
authors.affiliation: Saratov State Medical University Named After V.I. Razumovsky, Saratov, Russian Federation.
authors.forename: Tatiana G
authors.initials: TG
authors.lastname: Kamenskikh
authors.affiliation: Saratov State Medical University Named After V.I. Razumovsky, Saratov, Russian Federation.
authors.forename: Elena S
authors.initials: ES
authors.lastname: Sumarokova
authors.affiliation: Samara State Medical University, Samara, Russian Federation.
authors.forename: Eugeny S
authors.initials: ES
authors.lastname: Miljudin
authors.affiliation: Pirogov Russian National Research Medical University, Moscow, Russian Federation.
authors.forename: Eugeny A
authors.initials: EA
authors.lastname: Egorov
authors.affiliation: The Omsk State Medical Academy, Omsk, Russian Federation.
authors.forename: Oleg I
authors.initials: OI
authors.lastname: Lebedev
authors.affiliation: The Omsk State Medical Academy, Omsk, Russian Federation.
authors.forename: Alexander V
authors.initials: AV
authors.lastname: Surov
authors.affiliation: The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odessa, Ukraine.
authors.forename: Andrii R
authors.initials: AR
authors.lastname: Korol
authors.affiliation: The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odessa, Ukraine.
authors.forename: Illia O
authors.initials: IO
authors.lastname: Nasinnyk
authors.affiliation: Kharkiv National Medical University, Kharkiv, Ukraine.
authors.forename: Pavel A
authors.initials: PA
authors.lastname: Bezditko
authors.affiliation: Kharkiv National Medical University, Kharkiv, Ukraine.
authors.forename: Olena P
authors.initials: OP
authors.lastname: Muzhychuk
authors.affiliation: Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.|Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.
authors.forename: Vladimir A
authors.initials: VA
authors.lastname: Vygodin
authors.affiliation: Moscow Helmholtz Research Institute of Eye Diseases, Moscow, Russian Federation.
authors.forename: Elena V
authors.initials: EV
authors.lastname: Yani
authors.affiliation: Federal State Institution of Science Scientific Center of Biomedical Technology of the Federal Medical-Biological Agency of Russia, Svetlye Gory, Russian Federation.
authors.forename: Alla Y
authors.initials: AY
authors.lastname: Savchenko
authors.affiliation: 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.
authors.forename: Elena M
authors.initials: EM
authors.lastname: Karger
authors.affiliation: Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.|Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.
authors.forename: Oleg N
authors.initials: ON
authors.lastname: Fedorkin
authors.affiliation: Limited Liability Company, National Medicines Agency, Moscow, Russian Federation.
authors.forename: Alexander N
authors.initials: AN
authors.lastname: Mironov
authors.affiliation: 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.
authors.forename: Victoria
authors.initials: V
authors.lastname: Ostapenko
authors.affiliation: Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.
authors.forename: Natalia A
authors.initials: NA
authors.lastname: Popeko
authors.affiliation: Belozersky Institute of Physico-Chemical Biology, Lomonosov Moscow State University, Moscow, Russian Federation.
authors.forename: Vladimir P
authors.initials: VP
authors.lastname: Skulachev
authors.affiliation: Institute of Mitoengineering, Lomonosov Moscow State University, Moscow, Russian Federation.|Biological Faculty, Lomonosov Moscow State University, Moscow, Russian Federation.|Mitotech LLC, Moscow, Russian Federation.
authors.forename: Maxim V
authors.initials: MV
authors.lastname: Skulachev
mesh_terms: D000328:Adult; D001548:Benzalkonium Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003315:Cornea / Q000378:metabolism; D004311:Double-Blind Method; D004338:Drug Combinations; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D005260:Female; D019793:Fluorescein; D006801:Humans; D008297:Male; D008747:Methylcellulose / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010971:Plastoquinone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013666:Tears / Q000378:metabolism; D016896:Treatment Outcome; D014792:Visual Acuity
chemical_list: D001548:Benzalkonium Compounds; D004338:Drug Combinations; D009883:Ophthalmic Solutions; C000600714:Visomitin; D008747:Methylcellulose; D010971:Plastoquinone; D019793:Fluorescein
keywords: Dry eye syndrome; Mitochondria-targeted antioxidants; Ophthalmology; SkQ1