A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
NCT ID: NCT06666855
Last Updated: 2025-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
338 participants
INTERVENTIONAL
2024-11-28
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
NCT01868126
A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT
NCT01654484
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
NCT00650338
Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Once Daily and Twice Daily in Subjects With Primary Open-Angle Glaucoma SPECTRUM 6
NCT03858894
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension
NCT01343082
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DE-117B Eye Drops
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.
DE-117B Eye Drops
Investigational Product: 0.002% DE-117B Eye Drops
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.
Latanoprost
Active Control: 0.005% Latanoprost Eye Drops
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DE-117B Eye Drops
Investigational Product: 0.002% DE-117B Eye Drops
Latanoprost
Active Control: 0.005% Latanoprost Eye Drops
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Severe visual field disorder (e.g., mean deviation lower than -12 dB, as assessed by Humphrey field analyzer).
* Any corneal abnormality or other condition potentially interfering with reliable applanation tonometry.
* History of iritis or uveitis.
* Presence of any active external ocular disease, inflammation, or infection of the eye or eyelids.
* History of macular oedema, retinal detachment, or diabetic retinopathy, or current retinal disease at risk for progression during the study.
* History of refractive keratotomy.
* History of invasive surgery for glaucoma (including laser therapy).
* Anterior segment or intraocular surgery (other than glaucoma) within 90 days prior to start of washout phase.
* History of severe eye injury.
* History of allergy to agents that were to be used during the study (e.g., benzalkonium chloride, instillation anesthetics, fluorescein, latanoprost eye drops).
* Intended use of prohibited concomitant medications or therapies during the study.
* Required use of contact lenses from 1 week before treatment phase initiation and during the study.
* Pseudophakic eye, aphakic eye.
* Current participation in another clinical study, or participation and treatment with study medication within 90 days before the start of the washout phase.
* Females who are pregnant, nursing, or potentially pregnant (e.g., positive pregnancy test), planning a pregnancy during the study, or unable to use appropriate contraception during the study.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Santen Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Dr Tao Yong
Role: primary
Dr Wang Zheng
Role: primary
Dr Qing Guoping
Role: primary
Dr Wu Lingling
Role: primary
Dr Yu Minbin
Role: primary
Dr Xie Ping
Role: primary
Dr Wang Kaijun
Role: primary
Dr Shen Lijun
Role: primary
Dr Han Fangju
Role: primary
Dr Lv Peng
Role: primary
Dr Li Jingbo
Role: primary
Dr Pan Xiaojing
Role: primary
Dr Zou Haidong
Role: primary
Dr Huang Chukai
Role: primary
Dr Zhao Junmei
Role: primary
Dr Zhao Ping
Role: primary
Dr Liu Chi
Role: primary
Dr Yan Zhichao
Role: primary
Dr Yang Jin
Role: primary
Dr Wang Jibing
Role: primary
Dr Sun Zhong
Role: primary
Dr Peng Jianjun
Role: primary
Dr Ke Min
Role: primary
Dr Zhang Yinong
Role: primary
Dr Wang Yuhong
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0117B02CN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.