[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IIb study to evaluate the efficacy and safety of ZOC2017217 eye drops in patients with early and mid-stage senile cataract
主要目的:基于第12周时最佳矫正远视力(BCDVA)较基线的变化评估ZOC2017217滴眼液在早中期老年性白内障患者中的疗效,探索合适的给药方案。
次要目的:1.基于裸眼远视力(UCDVA)较基线的变化、晶状体混浊程度评分较基线的变化等次要疗效终点评估ZOC2017217滴眼液在早中期老年性白内障患者中的疗效。2.评估ZOC2017217滴眼液在早中期老年性白内障患者中的安全性。3. 评估ZOC2017217滴眼液在早中期老年性白内障患者中的血药浓度。
探索性目的:评估ZOC2017217滴眼液在早中期老年性白内障患者中近附加度数(ADD)较基线的变化。
[Translation] Primary objective: To evaluate the efficacy of ZOC2017217 eye drops in patients with early and middle-stage senile cataract based on the change of best corrected distance visual acuity (BCDVA) from baseline at week 12, and to explore the appropriate dosing regimen.
Secondary objectives: 1. To evaluate the efficacy of ZOC2017217 eye drops in patients with early and middle-stage senile cataract based on secondary efficacy endpoints such as the change of uncorrected distance visual acuity (UCDVA) from baseline and the change of lens opacity score from baseline. 2. To evaluate the safety of ZOC2017217 eye drops in patients with early and middle-stage senile cataract. 3. To evaluate the blood concentration of ZOC2017217 eye drops in patients with early and middle-stage senile cataract.
Exploratory objective: To evaluate the change of near added diopters (ADD) of ZOC2017217 eye drops in patients with early and middle-stage senile cataract from baseline.