[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the efficacy and safety of TUL12101 eye drops in the treatment of moderate to severe dry eye
主要目的:基于Schirmer I试验结果较基线的变化以及眼干症状评分较基线的变化评估TUL12101滴眼液治疗中重度干眼的临床疗效。
次要目的:评估TUL12101滴眼液治疗中重度干眼的临床疗效、安全性。评估TUL12101滴眼液在中重度干眼患者血液中的PK特征。评估TUL12101滴眼液在中重度干眼患者泪液中的PK、PD特征。
[Translation] Primary objective: To evaluate the clinical efficacy of TUL12101 eye drops in the treatment of moderate to severe dry eye based on the changes in Schirmer I test results from baseline and the changes in dry eye symptom scores from baseline.
Secondary objective: To evaluate the clinical efficacy and safety of TUL12101 eye drops in the treatment of moderate to severe dry eye. To evaluate the PK characteristics of TUL12101 eye drops in the blood of patients with moderate to severe dry eye. To evaluate the PK and PD characteristics of TUL12101 eye drops in the tears of patients with moderate to severe dry eye.