Comparison of Tear Evaporation Rate With DAILIES TOTAL1 and Biotrue ONEday
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tear Evaporation Rate With Nesofilcon A
研究概览
简要总结
The purpose of this pilot study is to compare the effect of DAILIES TOTAL1, a low water content silicone hydrogel lens, and Biotrue ONEday, a high water content hydrogel lens, on the rate of tear evaporation. The study will also serve to validate the novel, in-house developed evaporimeter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and investigators are masked as to which lens is assigned to each eye.
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
- •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;
- •Has worn soft contact lenses for a minimum of 6 months;
- •Currently wears soft contact lenses for at least 4 days per week and 8 hours per day;
- •Has an acceptable fit and comfort with both study contact lenses in the powers available;
- •Has less than or equal to 1.00DS difference between eyes in their habitual contact lenses;
- •Is willing to be awake for at least 2 hours before visit 2;
- •Is willing to not wear eye makeup on the day of visit 2 and 3;
- •Is willing to not use eye drops or artificial tears on the day of visits 1, 2, and 3;
- •Has a wearable pair of spectacles.
排除标准
- •Is participating in any concurrent clinical or research 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 sodium fluorescein dye;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- •Is aphakic;
- •Has undergone refractive error surgery;
- •Has a known sensitivity to petroleum jelly (Vaseline);
- •Has epilepsy and/or a sensitivity to flashing lights;
- •Wears toric contact lenses;
- •Has any physical impairment that would interfere with holding the evaporimeter;
- •Has taken part in another research study within the last 14 days.
结局指标
主要结局
Tear Evaporation Rate With Nesofilcon A
时间窗: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
Tear Evaporation Rate With Delefilcon A
时间窗: Baseline, 15 minutes post-contact lens, 6 hours post-contact lens
Tear film evaporation rate (% relative humidity per second) was performed using a novel evaporimeter as a non-invasive measurement of tear film evaporation. The slope was calculated from the change in humidity between 7 to 17.5 seconds while the eye was open and between 10 to 17.5 seconds when the eye was closed. Data from the both eyes were analyzed.
次要结局
未报告次要终点