Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A
研究概览
简要总结
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.
详细描述
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- 否
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
- •Is able to wear lenses for at least 12 hours a day.
排除标准
- •Is participating in any concurrent clinical study;
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- •Has undergone refractive error surgery;
- •*For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
结局指标
主要结局
Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A
时间窗: 12 Hours of Wear
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Moisture Retention (Mean) of Omafilcon A and Delefilcon A
时间窗: 12 Hours
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Moisture Retention (Median) of Omafilcon A and Delefilcon A
时间窗: 12 Hours
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A
时间窗: 12 Hours of Wear
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
次要结局
未报告次要终点