Effect of Contact Lenses on Tear Osmolarity in a Controlled Low Humidity Chamber
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Tear Osmolarity
研究概览
简要总结
The purpose of this study is to evaluate two different types of contact lenses and their effect on dry eyes when compared to wearing glasses in a controlled, low humidity chamber.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to
- •History of end-of-day or low-humidity dryness with contact lenses.
- •Healthy eyes.
- •Best-corrected visual acuity of 20/50 or better for each eye.
- •Usable pair of eye glasses.
- •Willing and able to attend required study visits.
- •Sign informed consent.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Ocular or systemic allergies or diseases which might interfere with contact lens wear.
- •Clinically significant ocular findings which would contraindicate contact lens wear.
- •Unable to abstain from artificial tears or other ophthalmic drops for at least 7 days.
- •Participation in another clinical study currently or within 30 days of study entry.
- •Spectacle astigmatism of >1.00 diopter.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Tear Osmolarity
时间窗: 90 minutes
The participant spent 90 minutes in the LHE (low humidity environment) chamber, after which tears were sampled from the lower tear meniscus (thin strip of tear fluid at the lower lid margin) and tear osmolarity was measured using a TearLab osmometer, a device that measures the osmolarity of human tears to aid in the diagnosis of dry eye disease. Tear osmolarity is the measure of solid particles (salt) in a solution (tears), and a higher number can be indicative of dry eye disease, while a lower number is generally indicative of the normal tear osmolarity.
Ocular Comfort
时间窗: 90 minutes
Ocular comfort was assessed by the participant after 90 minutes in the LHE and quantified as a linear measure (cm) on a modified Visual Analog Scale (VAS) of 0-20 cm, with a higher number indicating greater perceived comfort.
次要结局
未报告次要终点