Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear (CORNWALL)
2013年3月6日 更新者：CIBA VISION
Polymorphonuclear Leukocyte Response During Overnight Lens Wear
The purpose of this study was to count and analyze the white blood cells in tear samples collected from study participants following sleep.
The results from contact lens wearers were compared with the results from non-contact lens wearers.
研究概览
地位
完全的
条件
详细说明
The objective of the study was to determine and compare the relative oxidative response of polymorphonuclear neutrophils (PMNs), the relative cell adhesion response of PMNs, and the leukocyte population in tear samples collected from contact lens wearers and non-contact lens wearers.
Tear samples were collected via a binocular eye-wash.
The samples were processed, and a cell count was performed using a hemacytometer.
Flow cytometry was used to determine the expression of different PMN cell markers before and after stimulation with bacterial lipopolysaccharide (LPS).
研究类型
介入性
注册 (实际的)
65
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ontario
-
Waterloo、Ontario、加拿大、N2L 3G1
- University of Waterloo Centre for Contact Lens Research
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
17年 及以上 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 17 years of age or older.
- Ocular examination in the last two years.
- Has up-to-date spectacles.
Falls into one of the following three categories:
- Adapted wearer of Lotrafilcon A contact lenses
- Adapted wearer of Lotrafilcon B contact lenses
- Does not wear contact lenses
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Ocular disease
- Systemic or topical medications that may affect ocular health.
- Known sensitivity to diagnostic pharmaceuticals used in study.
- Uses artificial tears and/or rewetting drops.
- Wears contact lenses on an overnight basis for more than one night per week.
- Other protocol-defined exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Lotrafilcon A
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair.
After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
其他名称：
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
其他名称：
|
|
有源比较器：Lotrafilcon B
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair.
After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
|
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
其他名称：
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
其他名称：
|
|
无干预：No lens wear
No contact lens wear for the duration of the study.
One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
|
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 |
|---|---|---|
|
Leukocyte Population
大体时间：Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA).
Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes.
The total amount of leukocytes for contact lens wearers and non-lens wearers is presented.
Potential differences in leukocyte count between lens wearers and non-lens wearers may indicate a different immune response.
|
Week 5
|
|
Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
大体时间：Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer.
CD54 is a protein typically found in the cell membrane of leukocytes, which up-regulates during inflammation and promotes cell adhesion.
Cell adhesion response is reported as a ratio of stimulated to non-stimulated samples.
|
Week 5
|
|
Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
大体时间：Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer.
Oxidative response is reported as a ratio of activated to non-activated samples.
DCF (dichlorofluorescein diacetate) is a molecular probe that measures the oxidative burst.
Upon stimulation, the PMNs synthesize reactive oxygen species, such as superoxide or hydrogen peroxide, which is detected by the probe.
Differences in the oxidative response between contact lens wearers and non-lens wearers is indicated by a shift in the ratio (stimulated/unstimulated).
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Week 5
|
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Change From Week 1 in Leukocyte Population at Week 5
大体时间：Week 1, Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA).
Different types of white blood cells (leukocytes) were identified, which included neutrophils, monocytes, and lymphocytes.
The difference between total leukocytes for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
|
Week 1, Week 5
|
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Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
大体时间：Week 1, Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer.
Cell adhesion response is reported as a ratio of activated to non-activated samples.
The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
|
Week 1, Week 5
|
|
Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
大体时间：Week 1, Week 5
|
A tear sample was collected after 8 hours of sleep using an ocular surface cell collection apparatus (OSCCA) and analyzed on a flow cytometer.
Oxidative response is reported as a ratio of activated to non-activated samples.
The difference between the ratio data for contact lens wearers and non-lens wearers (Week 5 minus Week 1) is presented.
|
Week 1, Week 5
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Lyndon Jones, PhD FCOptom FAAO, Director、Centre for Contact Lens Research, School of Optometry, University of Waterloo
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年5月1日
初级完成 (实际的)
2012年1月1日
研究完成 (实际的)
2012年1月1日
研究注册日期
首次提交
2011年6月9日
首先提交符合 QC 标准的
2011年6月22日
首次发布 (估计)
2011年6月23日
研究记录更新
最后更新发布 (估计)
2013年3月8日
上次提交的符合 QC 标准的更新
2013年3月6日
最后验证
2013年3月1日
更多信息
与本研究相关的术语
其他研究编号
- P-373-C-102
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.