TY - JOUR
T1 - Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome
T2 - A Japanese phase 2 clinical trial
AU - Matsumoto, Yukihiro
AU - Ohashi, Yuichi
AU - Watanabe, Hitoshi
AU - Tsubota, Kazuo
PY - 2012/10
Y1 - 2012/10
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84867102487&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84867102487&partnerID=8YFLogxK
U2 - 10.1016/j.ophtha.2012.04.010
DO - 10.1016/j.ophtha.2012.04.010
M3 - Article
C2 - 22739038
AN - SCOPUS:84867102487
VL - 119
SP - 1954
EP - 1960
JO - Ophthalmology
JF - Ophthalmology
SN - 0161-6420
IS - 10
ER -