A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients

Br J Ophthalmol. 2012 Oct;96(10):1310-5. doi: 10.1136/bjophthalmol-2011-301448. Epub 2012 Aug 21.


Aims: To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. TRIAL DESIGN AND METHODS: In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks.

Results: After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was -0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference.

Conclusions: Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile.

Trial registration: ClinicalTrials.gov NCT01240382.

Publication types

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

MeSH terms

  • Cornea / drug effects
  • Cornea / pathology
  • Double-Blind Method
  • Dry Eye Syndromes / drug therapy*
  • Dry Eye Syndromes / pathology
  • Fluorescein
  • Fluorescent Dyes
  • Humans
  • Hyaluronic Acid / administration & dosage*
  • Hyaluronic Acid / adverse effects
  • Ophthalmic Solutions / administration & dosage*
  • Ophthalmic Solutions / adverse effects
  • Polyphosphates / administration & dosage*
  • Polyphosphates / adverse effects
  • Rose Bengal
  • Treatment Outcome
  • Uracil Nucleotides / administration & dosage*
  • Uracil Nucleotides / adverse effects
  • Viscosupplements / administration & dosage*
  • Viscosupplements / adverse effects


  • Fluorescent Dyes
  • Ophthalmic Solutions
  • Polyphosphates
  • Uracil Nucleotides
  • Viscosupplements
  • Rose Bengal
  • diquafosol
  • Hyaluronic Acid
  • Fluorescein

Associated data

  • ClinicalTrials.gov/NCT01240382