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RECRUITING
NCT06666855
PHASE3

A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China

Sponsor: Santen Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

DE-117B Eye Drops

Investigational Product: 0.002% DE-117B Eye Drops

DRUG

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