A 28-day Double-masked, Randomized, Parallel-group, Active Controlled Study of ONO-9054 Ophthalmic Solution in Subjects With Ocular Hypertension (OHT) or Open-angle Glaucoma (OAG)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 12
- 主要终点
- Evaluating the safety parameters per protocol
研究概览
简要总结
The primary objectives of this study are to compare the safety, tolerability, and mean change from baseline in diurnal intraocular pressure (IOP) of ONO-9054 30 µg/mL (0.003%) to latanoprost 0.005% following ocular instillation once every evening for 28 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-85 (inclusive) with confirmed diagnosis of OHT or OAG
- •Confirmed diagnosis of bilateral OHT or mild to moderate chronic OAG
- •Able to undergo washout of all ocular drugs
- •An IOP ≥ 24 mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least 1 eye; but < 36 mmHg in both eyes at both Day -5 and Day 1
- •Central corneal thickness 500-620 µm at screening and Day -5 in both eyes
- •Best corrected visual acuity (BCVA) of +0.7 Log Mar or better
排除标准
- •Any history of severe ocular trauma in either eye at any time
- •History of angle closure or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of Screening Visit in the study eye(s)
- •Cataracts that prevent observation or photography of the fundus in either eye
研究组 & 干预措施
Experimental Arm 1
ONO-9054 eye drop solution, 30 µg/mL (0.003%), once daily in both eyes, for 28 days.
干预措施: ONO-9054 (Drug)
Active Comparator Arm 2
Latanoprost eye drop solution, 0.005%, once daily in both eyes for 28 days.
干预措施: Latanoprost (Drug)
结局指标
主要结局
Evaluating the safety parameters per protocol
时间窗: 28 days
Physical and ocular examinations (tolerability, hyperemia, visual acuity, pupillometry, corneal thickness, aqueous cells and flare), vital signs, and safety laboratory evaluations
Mean change in diurnal IOP (average of four time points) from baseline
时间窗: 28 days
次要结局
- Diurnal IOP(28 days)
- Mean change from baseline in IOP at each measured time point(28 days)
- Treatment response rates(28 days)
- Percent change from baseline in IOP at each measured time point(28 days)