Actively Recruiting
A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
Led by Santen Pharmaceutical Co., Ltd. · Updated on 2025-02-28
338
Participants Needed
25
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary open angle glaucoma or ocular hypertension in both eyes
- Corrected visual acuity of 0.2 or better in both eyes
- Anterior chamber angle grade 2 or higher (Shaffer scale) in both eyes
- Central corneal thickness between 480 µm and 600 µm in both eyes
- Intraocular pressure of 22 mmHg or less in at least one eye and 34 mmHg or less in both eyes after washout at all measurement points
You will not qualify if you...
- Visual field disorder at risk of worsening during the study
- Severe visual field disorder (mean deviation worse than -12 dB by Humphrey field analyzer)
- Corneal abnormalities or other conditions interfering with reliable eye pressure measurement
- History of iritis or uveitis
- Active external eye disease, inflammation, or infection of eyes or eyelids
- History of macular edema, retinal detachment, diabetic retinopathy, or current retinal disease at risk of progression
- History of refractive keratotomy
- History of invasive glaucoma surgery including laser therapy
- Eye surgery other than glaucoma surgery within 90 days before washout
- History of severe eye injury
- Allergy to study agents such as benzalkonium chloride, anesthetics, fluorescein, or latanoprost
- Use of prohibited medications or therapies during the study
- Need to use contact lenses from 1 week before treatment and during study
- Pseudophakic or aphakic eye
- Participation in another clinical study or recent treatment with study medication within 90 days before washout
- Females who are pregnant, breastfeeding, possibly pregnant, planning pregnancy, or unable to use contraception during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 25 locations
1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Not Yet Recruiting
2
Beijing Hospital
Beijing, China
Actively Recruiting
3
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Actively Recruiting
4
Peking University Third Hospital
Beijing, China
Not Yet Recruiting
5
Zhongshan Ophthalmic Center
Guangzhou, China
Actively Recruiting
6
Affiliated Hospital of Guizhou Medical University
Guiyang, China
Actively Recruiting
7
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
8
Zhejiang Provincial People's Hospital
Hangzhou, China
Actively Recruiting
9
Jinan Second People's Hospital (Jinan eye hospital)
Jinan, China
Actively Recruiting
10
The Second Hospital & Clinical Medicial Lanzhou University
Lanzhou, China
Actively Recruiting
11
Luoyang third people's hospital
Luoyang, China
Actively Recruiting
12
Qingdao Eye Hospital of Shandong First Medical University
Qingdao, China
Not Yet Recruiting
13
Shanghai Eye Disease Prevention And Treatment Center/Shanghai Eye Hospital
Shanghai, China
Actively Recruiting
14
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, China
Actively Recruiting
15
Shanxi eye hospital
Shanxi, China
Actively Recruiting
16
Aier Eye Hospital (Liaoning)
Shenyang, China
Actively Recruiting
17
The 4th People's Hospital of Shenyang
Shenyang, China
Actively Recruiting
18
Shenzhen Eye Hospital
Shenzhen, China
Actively Recruiting
19
Tianjin Eye Hospital
Tianjin, China
Actively Recruiting
20
Weifang Eye Hospital
Weifang, China
Actively Recruiting
21
Wuhan Aier Eye Hospital
Wuhan, China
Actively Recruiting
22
Wuhan Puren Hospital
Wuhan, China
Actively Recruiting
23
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, China
Actively Recruiting
24
Wuxi Second People's Hospital
Wuxi, China
Actively Recruiting
25
Xiamen Eye Centre of Xiamen University Co., Ltd.
Xiamen, China
Actively Recruiting
Research Team
S
Santen Pharmaceuticals Co., Ltd Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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