Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome: a Japanese phase 2 clinical trial.
OBJECTIVE
To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome.


METHODS
Randomized, double-masked, multicenter, parallel-group, placebo-controlled trial.


METHODS
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.


METHODS
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.
Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan. ymatsumoto8@aol.com
Yukihiro
Y
Matsumoto
Yuichi
Y
Ohashi
Hitoshi
H
Watanabe
Kazuo
K
Tsubota
D000287:Administration, Topical; D003315:Cornea / Q000378:metabolism; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000378:metabolism; D005260:Female; D015590:Fluorophotometry; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D011122:Polyphosphates / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D058912:Purinergic P2Y Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D013666:Tears / Q000502:physiology; D016896:Treatment Outcome; D014500:Uracil Nucleotides / Q000008:administration & dosage* / Q000009:adverse effects
D009883:Ophthalmic Solutions; D011122:Polyphosphates; D058912:Purinergic P2Y Receptor Agonists; D014500:Uracil Nucleotides; C403315:diquafosol