A Double-masked, Placebo-controlled, Dose-escalation Study and Double-masked, Two-sequence, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ONO-9054 in Patients With Ocular Hypertension or Mild Open-Angle Glaucoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Safety and tolerability of ONO-9054
研究概览
简要总结
The primary objective of this study is to evaluate the safety and tolerability of 3 planned doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension (OHT) or mild open angle-glaucoma (OAG).
The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its tolerability following morning and evening dosing.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects age 18-80 (inclusive) with confirmed diagnosis of OHT or OAG
- •Confirmed diagnosis of bilateral OHT or chronic open-angle glaucoma
- •Able to undergo washout of all ocular drugs
- •An IOP ≥ 22mmHg at 8:00 AM and ≥ 21 mmHg at 10:00 AM in at least one eye; but ≤ 35 mmHg at all time points in both eyes on Day -2 and Day -1
- •Central corneal thickness 500-600 µm at screening in both eyes
- •BCVA 20/100 or better in both eyes
排除标准
- •Any history of severe ocular trauma in either eye at any time
- •Any history of previous intraocular 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 of the fundus in either eye
研究组 & 干预措施
Experimental Arm 1
Experimental Eye drops 3.0 µg/mL QD both eyes on Day 1, 5-18
干预措施: ONO-9054 (Drug)
Experimental Arm 2
Experimental Eye drops 10.0 µg/mL QD both eyes on Day 1, 5-18
干预措施: ONO-9054 (Drug)
Experimental Arm 3
Experimental Eye drop 30.0 µg/mL QD both eyes on day 1, 5-18
干预措施: ONO-9054 (Drug)
Experimental Arm 4
Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo
干预措施: ONO-9054 (Drug)
Experimental Arm 4
Experimental Eye drop, 2 sequence crossover Cohort [1 dose; 1-30 µg/mL]to be determined and placebo
干预措施: Placebo (Drug)
Placebo Arm
Matched placebo eye drops dosed in same manner as ONO-9054
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of ONO-9054
时间窗: up to 14 days
Safety and tolerability of ONO-9054 will be measured using vital signs, ECGs, laboratory tests, ocular exams, physical examination and incidence/severity of adverse events over a dosing period of up to 14 days
次要结局
- Characterization of PK profiles(up to 14 days)
- Comparison of safety, tolerability between once daily morning and once daily evening(14 days)
- Evaluation of PD measurements(up to 14 days)