研究单位:[1]Santen Pharmaceutical Co., Ltd.[2]Beijing Chao-Yang Hospital, Capital Medical University,Beijing,China[3]Beijing Hospital,Beijing,China[4]Beijing Tongren Hospital, Capital Medical University,Beijing,China[5]Peking University Third Hospital,Beijing,China[6]Zhongshan Ophthalmic Center,Guangzhou,China[7]Affiliated Hospital of Guizhou Medical University,Guiyang,China[8]The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,China[9]Zhejiang Provincial People''s Hospital,Hangzhou,China[10]Jinan Second People''s Hospital (Jinan eye hospital),Jinan,China[11]The Second Hospital & Clinical Medicial Lanzhou University,Lanzhou,China[12]Luoyang third people''s hospital,Luoyang,China[13]Qingdao Eye Hospital of Shandong First Medical University,Qingdao,China[14]Shanghai Eye Disease Prevention And Treatment Center/Shanghai Eye Hospital,Shanghai,China[15]Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong,Shantou,China[16]Shanxi eye hospital,Shanxi,China[17]Aier Eye Hospital (Liaoning),Shenyang,China[18]The 4th People''s Hospital of Shenyang,Shenyang,China[19]Shenzhen Eye Hospital,Shenzhen,China[20]Tianjin Eye Hospital,Tianjin,China[21]Weifang Eye Hospital,Weifang,China[22]Wuhan Aier Eye Hospital,Wuhan,China[23]Wuhan Puren Hospital,Wuhan,China[24]Zhongnan Hospital Affiliated to Wuhan University,Wuhan,China[25]Wuxi Second People''s Hospital,Wuxi,China[26]Xiamen Eye Centre of Xiamen University Co., Ltd.,Xiamen,China
研究目的:
This is a Phase III Study that includes a single arm, open-label, multi-dose PK study cohort and a randomized, evaluator-masked, active drug-control multicenter study. Subjects diagnosed with POAG (Primary Open Angle Glaucoma) or OHT (Ocular Hypertension) who meet eligibility criteria will washout of their current IOP lowering medication(s), if any. The study will investigate plasma pharmacokinetics of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension. It will investigate the safety of multi-dose 0.002% DE-117B eye drops (1 drop at a time administered once daily for 7 days) in Chinese subjects with primary open angle glaucoma or ocular hypertension. There will be a bridging cohort and extension follow-up phase