A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
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
1 other identifier
interventional
345
1 country
24
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2024
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedStudy Start
First participant enrolled
November 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
May 15, 2026
May 1, 2026
1.8 years
October 29, 2024
May 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Intraocular Pressure (IOP) at Week 4
Change from Baseline in Mean Diurnal IOP at Week 4
Week 4
Secondary Outcomes (4)
Percent Change in Intraocular Pressure (IOP)
Week 4
Change and Percent Change in Intraocular Pressure (IOP)
Post baseline Visits except Week 4
Change and Percent Change from baseline in Intraocular Pressure (IOP)
Assessment time point at each post baseline visit.
Percentage of Responders
Each Post Baseline Visit.
Study Arms (2)
DE-117B Eye Drops
EXPERIMENTAL0.002% 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 COMPARATOR0.005% 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Consider visual field disorder at risk for progression during the study based on the current clinical examination result.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
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
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2024
First Posted
October 31, 2024
Study Start
November 28, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share