A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) 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
- 20
- 试验地点
- 2
- 主要终点
- Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.
研究概览
简要总结
To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
详细描述
Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.
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
- •Must be 18 years of age or older
- •Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
- •Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
- •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 glaucoma, or narrow angles
- •Intraocular pressure ≥30 mmHg in either eye
- •A difference in IOP between eyes >4mmHg at qualification visit
- •Use of more than two ocular hypotensive medications within 30 days of screening
- •Known hypersensitivity to any component of the formulation
- •Previous glaucoma surgery or refractive surgery
- •Keratorefractive surgery in either eye
- •Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery 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
- •Mean central corneal thickness greater than 620 μm in either eye
- •Any abnormality preventing reliable applanation tonometry of either eye
- •Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)
- •Clinically significant abnormalities within 6 weeks prior to screening
- •Clinically significant systemic disease
- •Participation in any investigational study within 60 days prior to screening
- •Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
- •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
Netarsudil Ophthalmic Solution 0.02%
Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
干预措施: Netarsudil Ophthalmic Solution 0.02% (Drug)
Netarsudil Ophthalmic Solution 0.02%
Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
干预措施: Placebo Comparator (Other)
Placebo Comparator
Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye
干预措施: Netarsudil Ophthalmic Solution 0.02% (Drug)
Placebo Comparator
Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye
干预措施: Placebo Comparator (Other)
结局指标
主要结局
Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility.
时间窗: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility
时间窗: Study treatment was administered for 7 days, and outcome measures collected on Day 8
Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
次要结局
- Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)(Study treatment was administered for 7 days, and outcome measures collected on Day 8)
- Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP)(Study treatment was administered for 7 days, and outcome measures collected on Day 8)