A Masked, Randomized, Prospective, Single Center Crossover Clinical Trial on the Relationship Between Chemically Preserved Contact Lens Packaging Solutions and Bacterial Binding to Corneal Epithelial Cells
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Bacterial binding of Pseudomonas Aeruginosa
研究概览
简要总结
The goal of this study is to investigate the overall theory that the use of chemically preserved solutions associated with contact lenses promotes an increase in bacterial infection.
详细描述
The purpose of this study is to investigate the theory of bacterial binding to surface eye cells through the use of chemically preserved solutions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range: 18-38 years
- •Any sex, race or national origin accepted as with our past studies. Minority representation will be proactively encouraged.
- •No prior history of any contact lens wear within one month of entry into the study.
- •No history of allergic eye disease either seasonal or associated with previous contact lens wear.
排除标准
- •Any patient that is a current contact lens wearer.
- •Patients with active ocular infection or inflammatory disease, history of herpetic keratitis, glaucoma, etc.
- •Uncontrolled systemic disease or the presence of any significant illness or condition that could, in the judgment of the investigator, interfere with interpretation of the study results.
- •Any patient using ocular tears, anti-histamine based ocular therapies, glaucoma therapy, vasoconstricting drops, etc.
研究组 & 干预措施
Contact Lens Packaging Solution #1
Test solution - contact lens packaging solution
干预措施: Contact lens packaging solution (Device)
Contact lens packaging solution #2
Test solution - contact lens packaging solution
干预措施: Contact lens packaging solution (Device)
Balanced salt solution
Control solution
干预措施: Balanced salt solution (BSS) (Device)
结局指标
主要结局
Bacterial binding of Pseudomonas Aeruginosa
时间窗: 5 weeks
Counting the number of bacteria that bind to surface epithelial cells.
次要结局
未报告次要终点
研究者
Danielle Robertson
Assistant Professor
University of Texas Southwestern Medical Center