Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
Sponsor: Santen Pharmaceutical Co., Ltd.
Summary
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
Official title: A Phase III Study Including a Single-Arm, Open-Label, Multi-Dose PK Study Cohort and a Randomized, Evaluator-Masked, Active Drug Controlled, Parallel Group, Multicenter, Bridging Study Cohort With a Long-term Follow-up Phase Assessing the Efficacy and Safety of DE-117B Eye Drops in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
338
Start Date
2024-11-28
Completion Date
2026-03-31
Last Updated
2025-02-28
Healthy Volunteers
No
Conditions
Interventions
DE-117B Eye Drops
Investigational Product: 0.002% DE-117B Eye Drops
Latanoprost
Active Control: 0.005% Latanoprost Eye Drops
Locations (25)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
Zhongshan Ophthalmic Center
Guangzhou, China
Affiliated Hospital of Guizhou Medical University
Guiyang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
Jinan Second People's Hospital (Jinan eye hospital)
Jinan, China
The Second Hospital & Clinical Medicial Lanzhou University
Lanzhou, China
Luoyang third people's hospital
Luoyang, China
Qingdao Eye Hospital of Shandong First Medical University
Qingdao, China
Shanghai Eye Disease Prevention And Treatment Center/Shanghai Eye Hospital
Shanghai, China
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, China
Shanxi eye hospital
Shanxi, China
Aier Eye Hospital (Liaoning)
Shenyang, China
The 4th People's Hospital of Shenyang
Shenyang, China
Shenzhen Eye Hospital
Shenzhen, China
Tianjin Eye Hospital
Tianjin, China
Weifang Eye Hospital
Weifang, China
Wuhan Aier Eye Hospital
Wuhan, China
Wuhan Puren Hospital
Wuhan, China
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, China
Wuxi Second People's Hospital
Wuxi, China
Xiamen Eye Centre of Xiamen University Co., Ltd.
Xiamen, China