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
Status: Recruiting
Location: See all (25) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients diagnosed with primary open angle glaucoma or ocular hypertension in both eyes.
• Corrected visual acuity ≥0.2 in both eyes.
• Anterior chamber angle grade ≥2 (Shaffer scale) in both eyes.
• Central corneal thickness ≥480 μm to ≤600 μm in both eyes.
• At completion of the washout phase, IOP ≥22 mmHg in at least one eye and ≤34 mmHg in both eyes at all measurement time points.
Locations
Other Locations
China
Beijing Chao-Yang Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Beijing Hospital
RECRUITING
Beijing
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Zhongshan Ophthalmic Center
RECRUITING
Guangzhou
Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Jinan Second People's Hospital (Jinan eye hospital)
RECRUITING
Jinan
The Second Hospital & Clinical Medicial Lanzhou University
RECRUITING
Lanzhou
Luoyang third people's hospital
RECRUITING
Luoyang
Qingdao Eye Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Qingdao
Shanghai Eye Disease Prevention And Treatment Center/Shanghai Eye Hospital
RECRUITING
Shanghai
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
0.002% DE-117B Eye Drops - One drop daily, 9:00 PM±1 hours instilled in both eyes for 4 weeks, followed by 0.002% DE-117B Eye Drops - One drop daily, 9:00 PM±1 hours instilled in both eyes for an extension follow-up phase of 12 months.
Active_comparator: Latanoprost Eye Drops
0.005% Latanoprost Eye Drops - One drop daily, 9:00 PM±1 hours instilled in both eyes for 4 weeks, followed by 0.002% DE-117B Eye Drops - One drop daily, 9:00 PM±1 hours instilled in both eyes for an extension follow-up phase of 12 months.