Contact Lens Adaptation in Neophytes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
研究概览
简要总结
Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.
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
- Single (Investigator)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has had a completed comprehensive eye exam within the past 6 months
- •Able to wear spherical senofilcon A contact lenses
- •Able to use Opti-Free PureMoist contact lens solution
排除标准
- •Any prior contact lens use
- •Topical eye drops within the last two hours of the study visit
- •Known systemic health conditions known to alter tear film physiology
- •History of severe ocular trauma
- •Active ocular infection
- •Active ocular inflammation
- •Known hypersensitivity to diagnostic eye drops
- •Pregnant or breast feeding
结局指标
主要结局
Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
时间窗: 2 weeks
This is an eye comfort survey. The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
次要结局
- Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores(2-Weeks)
- Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)(2 Weeks)
- Between-Group Difference in Tear Volume as Measured by Schirmer's Test I(2 Weeks)
- Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart(2 weeks)
- Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M(2 Weeks)
- Between-Group Difference in Corneal Sodium Fluorescein Staining(2 Weeks)
- Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)(2 Weeks)
- Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)(2 Weeks)
- Between-Group Difference in Upper and Lower Eyelid Blepharitis(2 Weeks)
研究者
Andrew Pucker
Senior Research Associate
Ohio State University