[Translation] A randomized, double-blind, placebo-controlled Phase II clinical study evaluating the efficacy, safety, and topical pharmacokinetics of different concentrations of PHP0101 eye drops in the treatment of presbyopia in Chinese patients
主要目的:与安慰剂对照,评价不同浓度PHP0101滴眼液治疗中国老视患者的有效性,为本品后续临床推荐剂量提供依据。
次要目的:与安慰剂对照,评价不同浓度PHP0101滴眼液治疗中国老视患者的有效性;评价PHP0101滴眼液治疗中国老视患者的安全性;评价PHP0101滴眼液在中国老视患者中的局部药代动力学
探索目的:与安慰剂对照,评价不同浓度PHP0101滴眼液对干眼的有效性。
[Translation] Primary Objective: To evaluate the efficacy of different concentrations of PHP0101 eye drops in the treatment of presbyopic patients in China, compared with placebo, to provide a basis for the subsequent recommended clinical dosage of this product.
Secondary Objectives: To evaluate the efficacy of different concentrations of PHP0101 eye drops in the treatment of presbyopic patients in China, compared with placebo; to evaluate the safety of PHP0101 eye drops in the treatment of presbyopic patients in China; and to evaluate the local pharmacokinetics of PHP0101 eye drops in presbyopic patients in China.
Exploratory Objective: To evaluate the efficacy of different concentrations of PHP0101 eye drops for dry eye, compared with placebo.