Corneal Epithelium Defect Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops in Patients With Corneal Epithelial Defects After TPRK
A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.
Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end of the study on D7. Statistical analysis was performed using SAS9.4 or above software. All statistical tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified. ;
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