Clinical usefulness of diquafosol for real-world dry eye patients: a prospective, open-label, non-interventional, observational study.
BACKGROUND
This study was designed to evaluate the efficacy and safety of 3% diquafosol ophthalmic solution in dry eye patients in clinical practice.


METHODS
Subjects were dry eye patients who had never used diquafosol, and observation was conducted prospectively over 2 months. The corneal and conjunctival fluorescein staining score, tear film break-up time, 12 dry eye-related subjective symptoms, patient-reported outcomes, and adverse events were investigated.


RESULTS
Data were collected from 465 medical institutions for 3,196 patients. Diquafosol led to significant improvement in all subjective symptoms and objective findings (P < 0.001, paired t test). Diquafosol was effective regardless of the degree of severity according to the corneal and conjunctival fluorescein staining score or therapeutic pattern. Overall, 76.0% patients responded that their condition had improved. Adverse reactions were observed in 6.3% of patients. The major adverse reactions were eye discharge, eye irritation, and eye pain.


CONCLUSIONS
Diquafosol was effective for various dry eye patients in clinical practice, and no significant safety-related problems occurred.
Ehime University School of Medicine, Ehime, Japan.
Masahiko
M
Yamaguchi
Takeshi
T
Nishijima
Jun
J
Shimazaki
Etsuko
E
Takamura
Norihiko
N
Yokoi
Hitoshi
H
Watanabe
Yuichi
Y
Ohashi
D003228:Conjunctiva / Q000473:pathology; D003315:Cornea / Q000473:pathology; D015352:Dry Eye Syndromes / Q000175:diagnosis / Q000188:drug therapy; D005260:Female; 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; 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