NCT01675609已完成2 期
A Single-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Ocular redness
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be at least 40 years of age
- •Must have normal ocular health
- •Must have history of redness relief drop use or desire to use
排除标准
- •Must not have any ocular/systemic health problems
- •Must agree to avoid disallowed medications
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Brimonidine Tartrate 0.025%
Experimental
干预措施: Brimonidine tartrate 0.025% (Drug)
结局指标
主要结局
Ocular redness
时间窗: at specified timepoints for up to 180 minutes
redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary
次要结局
- Ocular Redness(up to 5 minutes post study medication instillation)
研究者
研究点 (1)
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