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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
345
Investigational Product: 0.002% DE-117B Eye Drops
Active Control: 0.005% Latanoprost Eye Drops
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
Daqing People's Hospital
Heilongjiang, China
Jinan Second People's Hospital (Jinan eye hospital)
Jinan, China
...and 14 more locations
Intraocular Pressure (IOP) at Week 4
Change from Baseline in Mean Diurnal IOP at Week 4
Time frame: Week 4
Percent Change in Intraocular Pressure (IOP)
Percent Change from Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 4
Time frame: Week 4
Change and Percent Change in Intraocular Pressure (IOP)
Change and Percent Change from Baseline in Mean Diurnal IOP at each post baseline visit except week 4.
Time frame: Post baseline Visits except Week 4
Change and Percent Change from baseline in Intraocular Pressure (IOP)
Change and Percent Change from baseline in IOP at each IOP assessment time point at each post baseline visit.
Time frame: Assessment time point at each post baseline visit.
Percentage of Responders
Percentage of Responders (percent reduction from baseline in Mean Diurnal IOP: ≥20%, ≥25%, ≥30%) at each post baseline visit.
Time frame: Each Post Baseline Visit.
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