The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic suspension during 52 weeks in dry eye patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
154
Instillation,4times/day,for 52weeks
Unnamed facility
Kansai Region, Japan
Unnamed facility
Kanto Region, Japan
Unnamed facility
Kyushu Region, Japan
Unnamed facility
Tohoku Region, Japan
Unnamed facility
Tokai Region, Japan
Change From Baseline (CFB) in Fluorescein Corneal Staining (FCS) Score
FCS indicates the damage to the corneal epithelium. Per the National Eye Institute/Industry Workshop report, the cornea was divided into 5 fractions, each of which was given a staining score from 0 to 3, and the total score was calculated (0-15). 0 is better. Baseline scores and those obtained at each examination time point were compared (paired t-test).
Time frame: Baseline, Week2, Week4, Week28, Week52
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