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

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


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Benzalkonium Compounds / administration & dosage
  • Benzalkonium Compounds / adverse effects
  • Benzalkonium Compounds / therapeutic use*
  • Cornea / metabolism
  • Double-Blind Method
  • Drug Combinations
  • Dry Eye Syndromes / drug therapy*
  • Female
  • Fluorescein
  • Humans
  • Male
  • Methylcellulose / administration & dosage
  • Methylcellulose / adverse effects
  • Methylcellulose / therapeutic use*
  • Middle Aged
  • Ophthalmic Solutions / administration & dosage
  • Ophthalmic Solutions / adverse effects
  • Ophthalmic Solutions / therapeutic use*
  • Plastoquinone / administration & dosage
  • Plastoquinone / adverse effects
  • Plastoquinone / therapeutic use*
  • Tears / metabolism
  • Treatment Outcome
  • Visual Acuity


  • Benzalkonium Compounds
  • Drug Combinations
  • Ophthalmic Solutions
  • Visomitin
  • Methylcellulose
  • Plastoquinone
  • Fluorescein