Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 165
- 主要终点
- Change From Baseline in Average Eye Intraocular Pressure (IOP)
研究概览
简要总结
This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Ocular hypertension or primary open-angle glaucoma in each eye
- •Patient requires IOP lowering medication in each eye
排除标准
- •Ocular hyperemia or other ocular surface findings in either eye
- •Active ocular disease
- •Current or anticipated use of any topical ocular medication (including artificial tears) during the study
- •Intraocular surgery within past six months or unilateral cataract surgery.
- •Functionally significant visual field loss
- •Anticipated wearing of contact lenses during study
- •Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit
研究组 & 干预措施
AGN-210669 ophthalmic solution, 0.1%
One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
干预措施: AGN-210669 ophthalmic solution, 0.1% (Drug)
AGN-210669 ophthalmic solution, 0.075%
One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
干预措施: AGN-210669 ophthalmic solution, 0.075% (Drug)
AGN-210669 ophthalmic solution, 0.05%
One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
干预措施: AGN-210669 ophthalmic solution, 0.05% (Drug)
bimatoprost ophthalmic solution 0.03%
One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
干预措施: bimatoprost ophthalmic solution 0.03% (Drug)
结局指标
主要结局
Change From Baseline in Average Eye Intraocular Pressure (IOP)
时间窗: Baseline, Day 29 Hour 0
IOP is a measurement of the fluid pressure inside the eye. The average of the 2 eyes is used for the analyses. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive number change from baseline indicates an increase in IOP (worsening).
次要结局
未报告次要终点