A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Lastacaft ®
One drop Lastacaft ® in right eye or left eye based on randomization list once on Day 1 and once on Day 2
|
|
|
安慰剂比较：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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Conjunctival Inflammation at 1 Hour (+30 Minutes) Post CAC on Day 1
大体时间：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. |
1 hour (+30 minutes) post CAC on Day 1
|
|
Conjunctival Inflammation 1 Hour (+30 Minutes) Post CAC on Day 2
大体时间：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. |
1 hour (+30 minutes) post CAC on Day 2
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ocular Itching on Day 1 (15 Minutes Post-study Medication Instillation)
大体时间：15 minutes post-study medication instillation
|
CAC was performed 15 minutes after study medication instillation.
Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]).
The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.
|
15 minutes post-study medication instillation
|
|
Ocular Itching on Day 2 (15 Minutes Post-study Medication Instillation)
大体时间：15 minutes post-study medication instillation
|
CAC was performed 15 minutes after study medication instillation.
Ocular Itching was assessed by the patient on a 0-4 scale (0 = best [no itching] to 4 = worst [severe itching]).
The ocular itching score was averaged across all Lastacaft-treated eyes to create the average Lastacaft eye ocular itching score, and the ocular itching score was averaged across all Tears Naturale-treated eyes to create the average Tears Naturale eye ocular itching score.
|
15 minutes post-study medication instillation
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Lastacaft ®的临床试验
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Chung-Ang University Hosptial, Chung-Ang University...未知
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Coopervision, Inc.完全的