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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-117B Eye Drops | Experimental | 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. |
|
| Latanoprost Eye Drops | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-117B Eye Drops | Drug | Investigational Product: 0.002% DE-117B Eye Drops |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) at Week 4 | Change from Baseline in Mean Diurnal IOP at Week 4 | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Intraocular Pressure (IOP) | Percent Change from Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 4 | Week 4 |
| Change and Percent Change in Intraocular Pressure (IOP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University | Beijing | China | ||||
| Beijing Hospital |
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| Latanoprost |
| Drug |
Active Control: 0.005% Latanoprost Eye Drops |
|
Change and Percent Change from Baseline in Mean Diurnal IOP at each post baseline visit except week 4.
| 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. | 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. | Each Post Baseline Visit. |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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