Pilot Study for Investigating the Effect of the Bruder Eye Hydrating Compress on Contact Lens Discomfort in Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)
研究概览
简要总结
The purpose of this prospective study is to evaluate the benefits of using the Bruder Moist Heat Compress in contact lens wearers who report reduced comfortable wear time. This will be done by assessing for improvement in ocular oil gland function and comfortable contact lens wearing time after one month of daily warm compress application. The efficacy of the Bruder Moist Heat Compress applied once will be compared to twice daily application as well as compared to warm compress application using a wash cloth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Provide informed consent and authorization to disclose protected health information
- •Have habitual contact lens corrected visual acuity in each eye of at least 20/30
- •Willing to comply with protocol
- •Wear soft daily contact lenses for total wear time of at least 4 hours a day and at least 4 days a week on average over at least a 30 day period before enrollment
排除标准
- •Have any uncontrolled systemic disease that in the investigator's opinion could be expected to interfere with the study, for example, conditions associated with dry eye disease
- •Pregnant by self-report
- •Active ocular conditions: infection, allergic conjunctivitis, severe eyelid inflammation including anterior blepharitis
研究组 & 干预措施
Once Daily Application of Bruder compress
Ten minute application of the Bruder Moist Heat Compress in the evening after lens removal
干预措施: Bruder Moist Heat Compress (Device)
Twice Daily Application of Bruder compress
Ten minute application of the Bruder Moist Heat Compress in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
干预措施: Bruder Moist Heat Compress (Device)
Twice Daily Application of warm washcloth
Ten minute application of a hot-water warmed washcloth in the morning prior to contact lens insertion and ten minute application in the evening after lens removal
干预措施: Washcloth (Other)
结局指标
主要结局
Mean Change in the Duration of Subject-reported Comfortable Contact Lens Daily Wear Time (Hours Per Day)
时间窗: Baseline through 1 month
次要结局
未报告次要终点
研究者
Jason Nichols
principal investigator
University of Alabama at Birmingham