Clinical evaluation of the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome: a prospective, randomized, multicenter study

Eye (Lond). 2012 Oct;26(10):1363-8. doi: 10.1038/eye.2012.166. Epub 2012 Aug 10.

Abstract

Purpose: To assess the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome.

Methods: This study evaluated 64 eyes of 32 patients (age: 62.6±12.8 years (mean±SD)) in whom treatment with 0.1% sodium hyaluronate was insufficiently responsive. The eyes were randomly assigned to one of the two regimens in each patient: topical administration of sodium hyaluronate and diquafosol tetrasodium in one eye, and that of sodium hyaluronate in the other. Before treatment, and 2 and 4 weeks after treatment, we determined tear volume, tear film break-up time (BUT), fluorescein and rose bengal vital staining scores, subjective symptoms, and adverse events.

Results: We found a significant improvement in BUT (P=0.049, Dunnett test), fluorescein and rose bengal staining scores (P=0.02), and in subjective symptoms (P=0.004 for dry eye sensation, P=0.02 for pain, and P=0.02 for foreign body sensation) 4 weeks after treatment in the diquafosol eyes. On the other hand, we found no significant change in these parameters after treatment in the control eyes.

Conclusions: In dry eyes, where sodium hyaluronate monotherapy was insufficient, diquafosol tetrasodium was effective in improving objective and subjective symptoms, suggesting its viability as an option for the additive treatment of such eyes.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Drug Therapy, Combination
  • Dry Eye Syndromes / drug therapy*
  • Dry Eye Syndromes / metabolism
  • Dry Eye Syndromes / physiopathology
  • Female
  • Fluorescein / metabolism
  • Fluorescent Dyes / metabolism
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Hyaluronic Acid / adverse effects
  • Male
  • Middle Aged
  • Ophthalmic Solutions
  • Polyphosphates / administration & dosage*
  • Polyphosphates / adverse effects
  • Prospective Studies
  • Purinergic P2Y Receptor Agonists / administration & dosage*
  • Purinergic P2Y Receptor Agonists / adverse effects
  • Rose Bengal / metabolism
  • Tears / chemistry
  • Uracil Nucleotides / administration & dosage*
  • Uracil Nucleotides / adverse effects
  • Viscosupplements / administration & dosage*
  • Viscosupplements / adverse effects

Substances

  • Fluorescent Dyes
  • Ophthalmic Solutions
  • Polyphosphates
  • Purinergic P2Y Receptor Agonists
  • Uracil Nucleotides
  • Viscosupplements
  • Rose Bengal
  • diquafosol
  • Hyaluronic Acid
  • Fluorescein