A Prospective, Double-masked, Randomized, Multi-center, Active-controlled, Parallel-group 12-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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 718
- 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 and Latanoprost Ophthalmic Solution.
Following completion of the Month 12 study visit procedures, subjects will be offered the opportunity to participate in a 2-month observational (i.e., non-interventional) trial extension.
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 older
- •Diagnosis of open angle glaucoma or ocular hypertension in both eyes
- •Unmedicated intraocular pressure >20mmHg and <36mmHg in both eyes at 2 qualification visits. Both eyes had to qualify at all qualification visits
- •Corrected visual acuity equivalent to 20/200 Snellen or better
- •Able to give informed consent and follow study instructions
排除标准
- •Clinically significant ocular disease
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles
- •Unmedicated Intraocular pressure ≥36mmHg
- •Use of more than 2 ocular hypotensive medications within 30 days of screening
- •Known hypersensitivity to any component of the formulation
- •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
- •Used ocular medication in either eye of any kind within 30 days of screening
- •Mean central corneal thickness >620µm at screening
- •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
- •Used any systemic medication that could have a substantial effect on intraocular pressure within 30 days prior to screening
- •Women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
研究组 & 干预措施
AR-13324 Ophthalmic Solution 0.02%
Netarsudil 0.02% ophthalmic solution
干预措施: Netarsudil (AR-13324) Ophthalmic Solution 0.02% (Drug)
PG324 Ophthalmic Solution 0.02%/0.005%
Fixed combination of netarsudil 0.02%, latanoprost 0.005% ophthalmic solution
干预措施: PG324 Ophthalmic Solution 0.02%/0.005% (Drug)
Latanoprost Ophthalmic Solution 0.005%
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: Primary efficacy endpoint measured for 3 months (data collected at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90)
The primary efficacy variable was mean IOP at 08:00, 10:00 and 16:00 hours at Day 15, Day 43 and Day 90, as measured by Goldmann applanation tonometry. Secondary analysis were conducted as a part of safety measurements to month 12 on treatment.
次要结局
- Extent of Exposure(12 months)