Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome: A Japanese phase 2 clinical trial

Yukihiro Matsumoto, Yuichi Ohashi, Hitoshi Watanabe, Kazuo Tsubota

Research output: Contribution to journalArticle

78 Citations (Scopus)

Abstract

Objective: To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome. Design: Randomized, double-masked, multicenter, parallel-group, placebo-controlled trial. Participants: A total of 286 Japanese patients with dry eye who were prescribed topical diquafosol (1%, n = 96; 3%, n = 96) or placebo ophthalmic solution (n = 94). Methods: After a washout period of 2 weeks, qualified subjects were randomized to receive a single drop of 1% or 3% diquafosol or placebo ophthalmic solutions 6 times per day for 6 weeks. Main Outcome Measures: The primary outcome measure was fluorescein corneal staining score assessment. The secondary outcome measures were Rose Bengal corneal and conjunctival staining scores, tear break-up time (BUT), and subjective symptom assessment. Safety measures were clinical blood and urine examination and recording of adverse events. Results: Fluorescein corneal staining scores significantly improved with both 1% and 3% topical diquafosol compared with placebo at 4 weeks, respectively (P = 0.037, P = 0.002). There was a dose-dependent effect among the groups. Rose Bengal corneal and conjunctival staining scores also improved significantly with both 1% and 3% diquafosol compared with placebo (P = 0.007 and P = 0.004, respectively). Subjective dry eye symptom scores significantly improved with both diquafosol ophthalmic solutions (P ≤ 0.033), although there were no significant differences in BUT compared with placebo. No significant differences between the treatment groups were observed in relation to the occurrence of adverse events. Conclusions: Both 1% and 3% diquafosol ophthalmic solutions are considered effective and safe for the treatment of dry eye syndrome. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.

Original languageEnglish
Pages (from-to)1954-1960
Number of pages7
JournalOphthalmology
Volume119
Issue number10
DOIs
Publication statusPublished - 2012 Oct

Fingerprint

Dry Eye Syndromes
Ophthalmic Solutions
Clinical Trials
Safety
Placebos
Staining and Labeling
Rose Bengal
Disclosure
Outcome Assessment (Health Care)
Fluorescein
Symptom Assessment
diquafosol
Tears
Therapeutics
Urine

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome : A Japanese phase 2 clinical trial. / Matsumoto, Yukihiro; Ohashi, Yuichi; Watanabe, Hitoshi; Tsubota, Kazuo.

In: Ophthalmology, Vol. 119, No. 10, 10.2012, p. 1954-1960.

Research output: Contribution to journalArticle

Matsumoto, Yukihiro ; Ohashi, Yuichi ; Watanabe, Hitoshi ; Tsubota, Kazuo. / Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome : A Japanese phase 2 clinical trial. In: Ophthalmology. 2012 ; Vol. 119, No. 10. pp. 1954-1960.
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abstract = "Objective: To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome. Design: Randomized, double-masked, multicenter, parallel-group, placebo-controlled trial. Participants: A total of 286 Japanese patients with dry eye who were prescribed topical diquafosol (1{\%}, n = 96; 3{\%}, n = 96) or placebo ophthalmic solution (n = 94). Methods: After a washout period of 2 weeks, qualified subjects were randomized to receive a single drop of 1{\%} or 3{\%} diquafosol or placebo ophthalmic solutions 6 times per day for 6 weeks. Main Outcome Measures: The primary outcome measure was fluorescein corneal staining score assessment. The secondary outcome measures were Rose Bengal corneal and conjunctival staining scores, tear break-up time (BUT), and subjective symptom assessment. Safety measures were clinical blood and urine examination and recording of adverse events. Results: Fluorescein corneal staining scores significantly improved with both 1{\%} and 3{\%} topical diquafosol compared with placebo at 4 weeks, respectively (P = 0.037, P = 0.002). There was a dose-dependent effect among the groups. Rose Bengal corneal and conjunctival staining scores also improved significantly with both 1{\%} and 3{\%} diquafosol compared with placebo (P = 0.007 and P = 0.004, respectively). Subjective dry eye symptom scores significantly improved with both diquafosol ophthalmic solutions (P ≤ 0.033), although there were no significant differences in BUT compared with placebo. No significant differences between the treatment groups were observed in relation to the occurrence of adverse events. Conclusions: Both 1{\%} and 3{\%} diquafosol ophthalmic solutions are considered effective and safe for the treatment of dry eye syndrome. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.",
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