[Translation] A phase II clinical study on the efficacy and safety of ZOC2019619 eye drops in the treatment of primary open-angle glaucoma or ocular hypertension: a multicenter, randomized, double-blind, parallel, placebo- or timolol eye drops-controlled study
主要目的:评估不同剂量和给药频次的ZOC2019619滴眼液对比噻吗洛尔滴眼液在原发性开角型青光眼(POAG)或高眼压症(OHT)患者中的疗效。
次要目的:1.评估不同剂量和给药频次的ZOC2019619滴眼液对比安慰剂在原发性开角型青光眼(POAG)或高眼压症(OHT)患者中的疗效;2.评估不同剂量和给药频次的ZOC2019619滴眼液对比安慰剂或者噻吗洛尔滴眼液在POAG或OHT患者中的眼部和全身的安全性。3.评估不同剂量和给药频次的ZOC2019619滴眼液在POAG或OHT患者中的药代动力学(PK)特征。
探索性目的:评估不同剂量和给药频次对POAG或OHT患者的日/夜间眼压波动的影响。
[Translation] Primary objective: To evaluate the efficacy of ZOC2019619 eye drops with different doses and dosing frequencies compared with timolol eye drops in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT).
Secondary objectives: 1. To evaluate the efficacy of ZOC2019619 eye drops with different doses and dosing frequencies compared with placebo in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT); 2. To evaluate the ocular and systemic safety of ZOC2019619 eye drops with different doses and dosing frequencies compared with placebo or timolol eye drops in patients with POAG or OHT. 3. To evaluate the pharmacokinetic (PK) characteristics of ZOC2019619 eye drops with different doses and dosing frequencies in patients with POAG or OHT.
Exploratory objective: To evaluate the effects of different doses and dosing frequencies on day/night intraocular pressure fluctuations in patients with POAG or OHT.