NCT01275105已完成2 期
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
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
- 68
- 试验地点
- 1
- 主要终点
- Conjunctival Redness
研究概览
简要总结
The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.
It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Be at least 18 years of age;
- •If female, cannot be not pregnant or nursing
- •Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees within the past 24 months;
- •Have a calculated best corrected visual acuity of 0.6 logMAR or better in each eye as measured using an ETDRS chart;
排除标准
- •Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
- •Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;
- •Have a presence of active ocular infection;
- •Use specified disallowed medications during the study or appropriate pre-study washout period;
- •Have any significant illness;
- •Have planned surgery (ocular or systemic) during the trial period or within 30 days after;
- •Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
- •Be a female who is currently pregnant or nursing.
研究组 & 干预措施
Vehicle
Other
干预措施: Vehicle (Drug)
Brimonidine Tartrate 0.01%
Active Comparator
干预措施: Brimonidine Tartrate 0.01% (Drug)
Oxymetazoline HCl 0.025%
Active Comparator
干预措施: Oxymetazoline HCl 0.025% (Drug)
Brimonidine Tartrate 0.025%
Active Comparator
干预措施: Brimonidine Tartrate 0.025% (Drug)
结局指标
主要结局
Conjunctival Redness
时间窗: at specified timepoints for up to 30 minutes
次要结局
未报告次要终点
研究者
研究点 (1)
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