NCT03310580已完成2 期
A Prospective, Double-masked, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Assessing the Safety and Ocular Hypotensive Efficacy and Optimum Concentration to be Used Clinically of Netarsudil Ophthalmic Solution in Japanese/Japanese-American Subjects With Open-angle Glaucoma or Ocular Hypertension in the United States
Aerie Pharmaceuticals39 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年11月15日最近更新:
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
- 42
- 试验地点
- 39
- 主要终点
- Mean Diurnal IOP (Intraocular Pressure) (mmHg)
研究概览
简要总结
To test the safety and effectiveness of AR-13324 0.02% and 0.04% ophthalmic solution relative to placebo in Japanese/Japanese-American subjects with open-angle glaucoma or ocular hypertension in US.
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
- Triple (Participant, Care Provider, 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
- •Must be 18 years or older
- •Be of Japanese ethnicity within the 2nd generation defined as (a) 1st generation born in Japan, immigrated to US and (b) 2nd generation - parents are 1st generation and patient was born in US as an American citizen
- •Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
- •Medicated intraocular pressure >/= 15 mmHg and < 30 mmHg in both eyes at screening
- •OAG eyes - unmedicated IOP >/= 15 mmHg and < 35 mmHg at 2 qualification visits at 08:00, 10:00 and 16:00
- •OHT eyes - unmedicated IOP >/= 22 mmHg and < 35mmHg at 08:00, 10:00 and 16:00
- •Best corrected visual acuity + 1.0 logMAR or better by ETDRS in each eye
- •Able to give signed informed consent and follow instructions
排除标准
- •Clinically significant ocular disease
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma or narrow angles
- •Intraocular pressure >/=35 mmHg in either eye
- •Ocular hyperemia score of moderate (+2) at qualification visit #2
- •Previous glaucoma intraocular surgery
- •Refractive surgery in either eye
- •Ocular injury within 6 months prior to screening or 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 the study
- •Mean central corneal thickness > 620 µm in either eye
- •Any abnormality preventing reliable applanation tonometry of either eye
- •Known hypersensitivity to benzalkonium chloride or excipients of netarsudil ophthalmic solution
- •Clinically significant abnormalities in screening lab tests
- •Clinically significant systemic disease that might interfere with the study
- •Participated in any investigational study within 30 days prior to screening
- •Systemic medication that could have a substantial effect on IOP within 30 days prior to screening or anticipated during the study
- •Women of child-bearing 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
AR-13324 Ophthalmic Solution 0.02%
Experimental
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
干预措施: AR-13324 Ophthalmic Solution 0.02% (Drug)
AR-13324 Ophthalmic Solution 0.04%
Experimental
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
干预措施: AR-13324 Ophthalmic Solution 0.04% (Drug)
Placebo Comparator
Placebo Comparator
Topical sterile ophthalmic solution; 1 drop daily to each eye for 28 days
干预措施: AR-13324 Ophthalmic Solution Placebo (Drug)
结局指标
主要结局
Mean Diurnal IOP (Intraocular Pressure) (mmHg)
时间窗: 28 Days
Mean diurnal intraocular pressure (IOP) at week 4, measured by Goldman Applanation Tonometry (GAT).
次要结局
- Extent of Exposure(28 Days)
研究者
研究点 (39)
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