NCT02674854已完成3 期
A Prospective, Double-masked, Randomized, Multi-center, Active Controlled, Parallel-group, 3-month Study Assessing the Safety and Ocular Hypotensive Efficacy of PG324 Ophthalmic Solution Compared to AR-13324 Ophthalmic Solution 0.02% and Latanoprost Ophthalmic Solution 0.005% in Subjects With Elevated Intraocular Pressure
Aerie Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
To evaluate ocular hypotensive efficacy and safety of PG324 Ophthalmic Solution compared to netarsudil (AR-13324) ophthalmic solution 0.02% and latanoprost ophthalmic solution 0.005%
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older (19 years of age or older in Canada)
- •Diagnosis of open angle glaucoma (OAG) or ocular hypertension(OHT) in both eyes
- •Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits
- •Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
- •Able to give informed consent and follow study instructions
排除标准
- •Ophthalmic:
- •Clinically significant ocular disease
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
- •Unmedicated intraocular pressure ≥36mmHg in either eye or use of more than 2 ocular hypotensive medications within 30 days of screening
- •Known hypersensitivity to any component of the formulation or latanoprost
- •Previous glaucoma surgery or refractive surgery
- •Ocular trauma within 6 months prior to screening
- •Any ocular surgery or non-refractive laser treatment within 3 months prior to screening
- •Recent or current ocular infection or inflammation in either eye
- •Use of ocular medication in either eye of any kind within 30 days of screening and throughout of the study
- •Mean central corneal thickness >620µm at screening in either eye
- •Any abnormality preventing reliable applanation tonometry of either eye
- •Clinically significant abnormalities in lab tests at screening
- •Clinically significant systemic disease
- •Participation in any investigational study within 60 days prior to screening
- •Systemic medication that could have had a substantial effect on IOP within 30 days prior to screening, or anticipated to be used during the study
- •Women of childbearing potential who were 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 0.02%/0.005%
Experimental
Fixed combination of netarsudil 0.02%, latanoprost 0.005 % ophthalmic solution
干预措施: PG324 Ophthalmic Solution 0.02%/0.005% (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: 3 months
Mean intraocular pressure(IOP) at 08:00, 10:00 and 16:00 hours, at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry.
次要结局
未报告次要终点
研究者
研究点 (1)
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