A Phase II, First-in-human Dose-escalation, Double-masked, Randomized, Vehicle-controlled, Dose-response Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-102 in Subjects With Elevated Intraocular Pressure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 8
- 主要终点
- The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.
研究概览
简要总结
A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.
详细描述
A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or greater (male, or female not of childbearing potential).
- •Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT) in the study eye(s).
- •Corrected visual acuity by ETDRS in each eye of +1.0 logMAR units or better
排除标准
- •Known hypersensitivity to any component of the formulation or to topical anesthetics
- •Previous glaucoma intraocular surgery or laser procedures in study eye(s)
- •Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, cardiovascular or endocrine disorders) which might interfere with the study.
- •Participation in any study involving an investigational drug within the past 30 days.
研究组 & 干预措施
AR-102 0.003% Ophthalmic Solution
q.d. ocular
干预措施: AR-102 0.003% Ophthalmic Solution (Drug)
AR-102 0.005% Ophthalmic Solution
q.d. ocular
干预措施: AR-102 0.005% Ophthalmic Solution (Drug)
AR-102 0.01% Ophthalmic Solution
q.d. ocular
干预措施: AR-102 0.01% Ophthalmic Solution (Drug)
AR-102 0.03% Ophthalmic Solution
q.d. ocular
干预措施: AR-102 0.03% Ophthalmic Solution (Drug)
AR-102 Vehicle Ophthalmic Solution
q.d. ocular
干预措施: AR-102 Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point.
时间窗: One week
次要结局
- The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject questionnaires(One week)