A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1
研究概览
简要总结
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
- •Have a positive CAC reaction at Visit 1
- •Have a positive conjunctival inflammation score at Visit 1
排除标准
- •May not use disallowed medications in specified washout period
- •May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
- •May not have active ocular infection
研究组 & 干预措施
Lastacaft ®
One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
干预措施: Lastacaft ® (Drug)
Tears Naturale ®
One drop Tears Naturale ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
干预措施: Tears Naturale ® (Placebo) (Drug)
结局指标
主要结局
Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1
时间窗: 1 hour (+30 minutes) post CAC on Day 1
Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best \[least inflammation\] and 4 = worst \[most inflammation\]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.
Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2
时间窗: 1 hour (+30 minutes) post CAC on Day 2
Conjunctival Inflammation was assessed by a trained technician post-conjunctival allergen challenge (CAC) on a 0 to 4 scale (0 = best \[least inflammation\] and 4 = worst \[most inflammation\]). The Conjunctival Inflammation was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye Conjunctival Inflammation score, and the Conjunctival Inflammation score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye Conjunctival Inflammation score.
次要结局
- Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)(15 minutes post-study medication instillation)
- Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)(15 minutes post-study medication instillation)