Efficacy and Safety of 0.2% Hyaluronic Acid in the Management of Dry Eye Disease

Eye Contact Lens. 2017 Jan;43(1):57-63. doi: 10.1097/ICL.0000000000000236.

Abstract

Objectives: To evaluate the safety and efficacy of a new artificial tear containing 0.2% hyaluronic acid, as compared with 0.9% saline solution, in mild dry eye patients after 1-month use in a crossover study design with washout periods.

Methods: Overall, 16 mild dry eye patients were included. After a week of washout, every patient used the experimental product (Visaid 0.2%) and the control product (0.9% saline solution), each for a month (3-8 drops daily). Both products were preservative free. The percentage change for the following variables were calculated and analyzed: Ocular Surface Disease Index (OSDI) questionnaire, visual acuity, intraocular pressure, ophthalmoscopy evaluation, biomicroscopy findings, fluorescein corneal staining and lissamine green conjunctival staining, tear breakup time, contrast sensitivity, Schirmer's test, and subject satisfaction.

Results: Patients reported an improvement (a significant decrease of -19.5%±27.5%) in OSDI scores after using Visaid 0.2% and a worsening (a significant increase of 19.2%±32.4%) after using 0.9% saline solution; the difference was significant (P=0.0087, Student's t test). Significant changes (P≤0.04, Wilcoxon's test) were found comparing Visaid 0.2% with saline solution for bulbar hyperemia (-39.1%±50.8% vs. 7.8%±12.0%, respectively), corneal staining (-26.0%±53.0% vs. 36.5%±73.3%), conjunctival staining (-54.7%±53.4% vs. -7.8%±47.2%), and subjective satisfaction (26.8%±28.5% vs. -13.3%±22.5%). There were no significant differences in the safety parameters for either solution.

Conclusion: This clinical trial demonstrates the safety of Visaid 0.2% and its clear benefit over 0.9% saline solution.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Contrast Sensitivity / physiology
  • Cross-Over Studies
  • Double-Blind Method
  • Dry Eye Syndromes / drug therapy*
  • Dry Eye Syndromes / physiopathology
  • Female
  • Humans
  • Hyaluronic Acid / adverse effects
  • Hyaluronic Acid / therapeutic use*
  • Intraocular Pressure / physiology
  • Lubricant Eye Drops / adverse effects
  • Lubricant Eye Drops / therapeutic use*
  • Male
  • Middle Aged
  • Ophthalmoscopy
  • Prospective Studies
  • Sodium Chloride
  • Surveys and Questionnaires
  • Treatment Outcome
  • Visual Acuity / physiology

Substances

  • Lubricant Eye Drops
  • Sodium Chloride
  • Hyaluronic Acid