NCT04863365Unknown3 期
A Multi-center, Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of PHP-201 in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
pH Pharma1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Intraocular Pressure
研究概览
简要总结
This is a phase 3 study to confirm the efficacy in reduction of intraocular pressure and safety of PHP-201 ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.
详细描述
As a selective ROCK inhibitor, PHP-201 is designed to alleviate the side effects, which are the disadvantages of existing intraocular pressure reducing agents, while exhibiting sufficient intraocular pressure-lowering effect in glaucoma patients. This clinical trial aims to provide a new therapeutic option by evaluating the efficacy and safety of PHP-201 0.5% in patients with primary open-angle glaucoma or ocular hypertension who require intraocular pressure reduction therapy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age of 19 years or older
- •Diagnosis of open-angle glaucoma (POAG) or ocular hypertension (OH)
- •Intraocular Pressure(IOP) ≤ 35mmHg at both eye and IOP ≥ 22mmHg at either eye
- •Shaffer's grading > 2
- •Best-corrected visual acuity in both eye equivalent to 0.2logMar
- •Able and willing to give signed informed consent
排除标准
- •Central corneal thickness <500㎛ or >600㎛
- •Medical history of following
- •Closed-angle glaucoma, pigment dispersion syndrome, pseudoexfoliation, narrow-angle glaucoma
- •Advanced glaucomatous loss; mean deviation (MD) < -12dB
- •Moderate to severe inflammatory/infectious disease in either eye
- •Advanced retinopathy
- •Surgical or laser therapy for glaucoma treatment
- •Have confirmed the following at the screening visit
- •SBP ≥ 180mmHg or DBP ≥ 110mmHg
- •HbA1c > 9.0%
- •CrCl < 30mL/min
- •AST or ALT ≥ 3 X ULN
- •Unstable angina, myocardial infarction, transient ischemic attack, cerebral stroke, coronary artery bypass graft, or coronary angioplasty within 24 weeks
- •History of malignant tumor with 5 years
- •History of the causative disease that may cause secondary glaucoma, including a history of steroid administration for more than 4 weeks
- •Conditions need to wear contact lenses during the study
- •Known hypersensitivity to any component of the investigational product
- •Who has administered topical/systemic drugs that may affect the study within a certain period prior to eligibility check or are expected to need administration during the study duration
- •Prostaglandin analogues: 5 weeks
- •β-blockers: 4 weeks
- •ROCK inhibitors: 4 weeks
- •α/β-adrenergic agonists: 2 weeks
- •Muscarinic agonists: 1 week
- •Carbonic anhydrase inhibitors: 1 week
- •Systemic corticosteroids: 4 weeks
- •Pregnant or breast-feeding
- •Who disagreed with the use of the methods of proper contraception during the study duration
- •Administration or use of other investigational drugs/devices prior to the screening visit within its 5 half-lives or 30 days, whichever is longer
- •Unsuitable for participation in the study according to the judgment of the investigator
研究组 & 干预措施
Placebo treatment
Placebo Comparator
A matching placebo ophthalmic solution, TID
干预措施: Placebo ophthalmic solution (Drug)
PHP-201 treatment
Experimental
PHP-201 0.5% ophthalmic solution, TID
干预措施: PHP-201 ophthalmic solution (Drug)
结局指标
主要结局
Intraocular Pressure
时间窗: 4 weeks
Mean IOP change from baseline
次要结局
- Diurnal intraocular pressure(4 weeks)
研究者
研究点 (1)
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