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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 345
- 试验地点
- 33
- 主要终点
- Intraocular Pressure (IOP) at Week 4
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: DE-117B Eye Drops (Drug)
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.
干预措施: Latanoprost (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) at Week 4
时间窗: Week 4
Change from Baseline in Mean Diurnal IOP at Week 4
次要结局
- 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.)