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A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients
  1. Etsuko Takamura1,
  2. Kazuo Tsubota2,
  3. Hitoshi Watanabe3,
  4. Yuichi Ohashi4,
  5. for The Diquafosol Ophthalmic Solution Phase 3 Study Group
  1. 1Department of Ophthalmology, Tokyo Women's Medical University, School of Medicine, Tokyo, Japan
  2. 2Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan
  3. 3Eye Division, Kansai Rosai Hospital, Hyogo, Japan
  4. 4Department of Ophthalmology, Ehime University School of Medicine, Ehime, Japan
  1. Correspondence to Dr Etsuko Takamura, Department of Ophthalmology, Tokyo Women's Medical University, School of Medicine, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan; takamura{at}


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.

  • Clinical Trial
  • Conjunctiva
  • Cornea
  • Drugs
  • Tears

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