A Single-masked, Randomized, Multi-center, Parallel-group, 4-week Study Evaluating the Efficacy and Safety of Once Daily Netarsudil Ophthalmic Solution 0.02% Compared to Twice Daily Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% in Japanese Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
A Phase 3 Study Comparing the Efficacy and Safety of Netarsudil Ophthalmic Solution 0.02% QD to Ripasudil Hydrochloride Hydrate Ophthalmic Solution 0.4% BID, for Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Over A 4-Week Period.
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)
盲法说明
This study adopted a single-masked study design. Treatment assignments were masked to the Investigator, the clinical study team (Sponsor, designated personnel involved in day-to-day study management, Monitors, Data Managers, and Statisticians), and the subjects for the duration of the study. The netarsudil and ripasudil bottles were different in the study, however, investigators and subjects were masked to study drug assignment.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years of age or older
- •Diagnosis of POAG or OHT in both eyes (POAG in one eye and OHT in the fellow eye was acceptable)
- •Medicated intraocular pressure (IOP) ≥ 14 mmHg in at least one eye and < 30 mmHg in both eyes at screening visit
- •For POAG eyes, unmedicated (post washout) IOP ≥ 15 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 15 mmHg and < 35 mmHg at 11:00 and 16:00 hour (in the same eye).
- •For OHT eyes, unmedicated (post washout) IOP ≥ 22 mmHg and < 35 mmHg in the study eye at 2 qualification visits (09:00 hours), 2-7 days apart. At second qualification visit IOP ≥ 22 mmHg and < 35 mmHg at 11:00 and 16:00 hours (in the same eye)
- •Best-corrected visual acuity (BCVA) +0.7 log MAR or better (20/100 Snellen or better or 0.20 or better in decimal unit) in each eye
- •Willingness and ability to give signed informed consent and follow study instructions
排除标准
- •Clinically significant ocular disease
- •Retinal diseases that may progress during the study period
- •Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
- •Previous glaucoma intraocular surgery
- •Refractive surgery in either eye
- •Ocular hyperemia score of moderate (+2) or severe (+3) at Qualification Visit #2
- •Ocular trauma
- •Ocular infection or inflammation
- •Any corneal disease that may confound assessment
- •Evidence of corneal deposits or cornea verticillata
- •Known hypersensitivity to any component of netarsudil ophthalmic solution 0.02%, ripasudil hydrochloride hydrate ophthalmic solution 0.4%, or to topical anesthetic.
- •Mean central corneal thickness >620 um
- •Any abnormality preventing reliable Goldmann applanation tonometry of either eye (e.g. keratoconus)
- •Cannot demonstrate proper delivery of the eye drop
- •Clinically significant systemic disease
- •Participation in any investigational study within 30 days prior to screening
- •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
Netarsudil ophthalmic solution 0.02% and netarsudil ophthalmic solution vehicle
1 drop netarsudil 0.02% in the evening and 1 drop netarsudil vehicle in the morning in each eye.
干预措施: Netarsudil ophthalmic solution 0.02% (Drug)
Ripasudil hydrochloride hydrate ophthalmic solution 0.4%
1 drop ripasudil twice daily in the morning and evening in each eye.
干预措施: Ripasudil hydrochloride hydrate ophthalmic solution 0.4% (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: 29 Days
Comparison of both groups mean diurnal IOP at Week 4 (Day 29). IOP will be measured by Goldmann applanation tonometry and reported in millimeters mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Mean diurnal IOP was calculated as the average of 3 IOP values across 09:00, 11:00 and 16:00 time points.
次要结局
- Mean Change IOP From Baseline at Days 8, 15, 29(Baseline (Day 1), Days 8, 15, 29)
- IOP at Weeks 1 and 2(Day 8, Day 15)