Clinical trial NCT06666855: A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-31
Enrollment: 338
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intraocular Pressure (IOP) at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Percent Change in Intraocular Pressure (IOP)
timeFrame: Week 4
measure: Change and Percent Change in Intraocular Pressure (IOP)
timeFrame: Post baseline Visits except Week 4
measure: Change and Percent Change from baseline in Intraocular Pressure (IOP)
timeFrame: Assessment time point at each post baseline visit.
measure: Percentage of Responders
timeFrame: Each Post Baseline Visit.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
city: Guiyang
country: China
facility: Affiliated Hospital of Guizhou Medical University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Jinan
country: China
facility: Jinan Second People's Hospital (Jinan eye hospital)
city: Lanzhou
country: China
facility: The Second Hospital & Clinical Medicial Lanzhou University
city: Luoyang
country: China
facility: Luoyang third people's hospital
city: Qingdao
country: China
facility: Qingdao Eye Hospital of Shandong First Medical University
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention And Treatment Center/Shanghai Eye Hospital
city: Shantou
country: China
facility: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
city: Shanxi
country: China
facility: Shanxi eye hospital
city: Shenyang
country: China
facility: Aier Eye Hospital (Liaoning)
city: Shenyang
country: China
facility: The 4th People's Hospital of Shenyang
city: Shenzhen
country: China
facility: Shenzhen Eye Hospital
city: Tianjin
country: China
facility: Tianjin Eye Hospital
city: Weifang
country: China
facility: Weifang Eye Hospital
city: Wuhan
country: China
facility: Wuhan Aier Eye Hospital
city: Wuhan
country: China
facility: Wuhan Puren Hospital
city: Wuhan
country: China
facility: Zhongnan Hospital Affiliated to Wuhan University
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
city: Xiamen
country: China
facility: Xiamen Eye Centre of Xiamen University Co., Ltd.
Study officials:
References: