A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
- Conditions
- Open Angle GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT06666855
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 338
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DE-117B Eye Drops 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. Latanoprost Eye Drops Latanoprost 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.
- Primary Outcome Measures
Name Time Method Intraocular Pressure (IOP) at Week 4 Week 4 Change from Baseline in Mean Diurnal IOP at Week 4
- Secondary Outcome Measures
Name Time Method Percent Change in Intraocular Pressure (IOP) Week 4 Percent Change from Baseline in Mean Diurnal Intraocular Pressure (IOP) at Week 4
Change and Percent Change in Intraocular Pressure (IOP) Post baseline Visits except Week 4 Change and Percent Change from Baseline in Mean Diurnal IOP at each post baseline visit except week 4.
Change and Percent Change from baseline in Intraocular Pressure (IOP) Assessment time point at each post baseline visit. Change and Percent Change from baseline in IOP at each IOP assessment time point at each post baseline visit.
Percentage of Responders Each Post Baseline Visit. Percentage of Responders (percent reduction from baseline in Mean Diurnal IOP: ≥20%, ≥25%, ≥30%) at each post baseline visit.
Related Research Topics
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Trial Locations
- Locations (25)
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
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
Wuhan Puren Hospital
🇨🇳Wuhan, China
Wuhan Aier Eye Hospital
🇨🇳Wuhan, China