A Phase 2a, Multicenter, Randomized, Double-masked, Placebo-controlled, Parallel-group Study of AMA0076 in Topical Ocular Formulation for Safety, Tolerability and Efficacy in Reduction of Intraocular Pressure in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amakem, NV
- 入组人数
- 103
- 试验地点
- 9
- 主要终点
- Mean change from baseline in mean diurnal intraocular pressure
研究概览
简要总结
The objective of this parallel group study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 30-85 years of age.
- •Diagnosis of either POAG or OHT in both eyes.
- •Not receiving medication for IOP, or able to stop such medication for a washout period and the duration of the study without significant risk of adverse consequences related to glaucomatous disease.
- •Elevated IOP (≥ 24 and ≤ 33 mm Hg at 8 AM and ≥ 21 and ≤ 33 mm Hg at 10 AM on Screening Two visit and Baseline visit in one or both eyes off treatment [after a washout phase in those subjects who were receiving ocular hypotensive therapy]).
排除标准
- •Ophthalmic exclusion criteria:
- •Uncontrolled intraocular hypertension defined as > 33 mm Hg in either eye at either of the screening/baseline visits (after a washout phase in those subjects who were currently receiving ocular hypotensive therapy).
- •Receiving more than one medication for IOP in either eye at time of screening.
- •Abnormal central corneal thickness.
- •BCVA worse than 20/200 (logMAR 1.0) in either eye
- •Significant visual field loss.
- •Acute angle-closure glaucoma or appositional or very narrow anterior chamber angle in either eye.
研究组 & 干预措施
AMA0076 0.1%
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
干预措施: AMA0076 (Drug)
AMA0076 0.25%
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
干预措施: AMA0076 (Drug)
AMA0076 0.50%
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
干预措施: AMA0076 (Drug)
Placebo
Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change from baseline in mean diurnal intraocular pressure
时间窗: 4 weeks
次要结局
- Mean, mean change and percent change from baseline in intraocular pressure in both mean diurnal intraocular pressure and intraocular pressure at equivalent diurnal time points.(4 weeks)
- Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables(4 weeks)