Polymorphonuclear Leukocyte Response During Overnight Lens Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change From 1 Week in Relative Cell Adhesion Response of PMNs at Week 5
时间窗: 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.
Leukocyte Population
时间窗: 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.
Relative Cell Adhesion Response of Polymorphonuclear Leukocytes (PMNs)
时间窗: 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.
Relative Oxidative Response of Polymorphonuclear Leukocytes (PMNs)
时间窗: 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).
Change From Week 1 in Leukocyte Population at Week 5
时间窗: 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.
Change From Week 1 in Relative Oxidative Response of PMNs at Week 5
时间窗: 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.
次要结局
未报告次要终点