NCT02057575已完成2 期
A Double-masked, Randomized, Controlled Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution, 0.01% and PG324 Ophthalmic Solution, 0.02%, Compared to AR-13324 Ophthalmic Solution, 0.02% and Latanoprost Ophthalmic Solution, 0.005% in Patients With Elevated Intraocular Pressure
Aerie Pharmaceuticals23 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 298
- 试验地点
- 23
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
To evaluate the ocular hypotensive efficacy of PG324 ophthalmic solution relative to its individual components in patients with open angle glaucoma or ocular hypertension.
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.
- •Diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT)
- •Corrected visual acuity in each eye equivalent to 20/200 or better
- •Able and willing to give signed informed consent and follow study instructions.
排除标准
- •Ophthalmic:
- •Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure, or narrow angles.
- •Intraocular pressure >36 mmHg
- •Known hypersensitivity to any component of the formulation, latanoprost, or to topical anesthetics.
- •Previous glaucoma intraocular surgery or glaucoma laser procedures in study eye(s)
- •Refractive surgery in study eye(s)
- •Ocular trauma within the six months prior to screening, or ocular surgery or laser treatment within the three months prior to screening.
- •Evidence of ocular infection and inflammation
- •Clinically significant ocular disease, which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe
- •Central corneal thickness greater then 600 μm
- •Any abnormality preventing reliable applanation tonometry of either eye
- •Clinically significant abnormalities (as determined by the investigator) in laboratory tests at screening.
- •Clinically significant systemic disease
- •Participation in any investigational study within 30 days prior to screening
- •Changes in systemic medication
- •Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
研究组 & 干预措施
PG324 Ophthalmic Solution 0.01%
Experimental
Netarsudil 0.01%, Latanoprost 0.005% fixed combination ophthalmic solution
干预措施: PG324 Ophthalmic Solution 0.01% (Drug)
PG324 Ophthalmic Solution 0.02%
Experimental
Netarsudil 0.02%, Latanoprost 0.005% fixed combination ophthalmic solution
干预措施: PG324 Ophthalmic Solution 0.02% (Drug)
Netarsudil (AR-13324) Ophthalmic Solution 0.02%
Active Comparator
Netarsudil 0.02% ophthalmic solution
干预措施: Netarsudil (AR-13324) Ophthalmic Solution 0.02% (Drug)
Latanoprost Ophthalmic Solution 0.005%
Active Comparator
Latanoprost 0.005% ophthalmic solution
干预措施: Latanoprost Ophthalmic Solution 0.005% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: Study treatment was administered for 28 days, and outcome measures collected on Day 29
The primary efficacy endpoint was the mean diurnal IOP across subjects within treatment group at Day 29.
次要结局
未报告次要终点
研究者
研究点 (23)
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