The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Lid Wiper Epitheliopathy
研究概览
简要总结
This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF)
详细描述
The primary study objectives are to determine the amount of Lid Wiper Epitheliopathy (LWE) induced in subjects after contact lens fitting that do not have LWE at study enrollment. Subjects in the trial will be fit in 2 contact lenses with different coefficients of friction (CoF). One eye will be fit in a contact lens with a low coefficient of friction (Acuvue Oasys®, Johnson & Johnson Vision, Jacksonville FL) while the contralateral eye will be fit in a contact lens with a high CoF (Air Optix® Night & Day® Aqua, Ft. Worth, TX), as reported in the scientific literature. The eye receiving each lens will be assigned randomly. The presence of LWE will be assessed at 2 different time points, approximately 2 hours after contact lens fitting and approximately after 7 days of contact lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subjects will be masked to the contact lens brand fit in each eye. The subject's Lid Wiper Epitheliopathy will be graded using photographs of the eyelid, where the grader is masked to the lens type in each eye.
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to read and understand the study informed consent
- •Must be a minimum of 18 years of age and less than 46 years of age at study enrollment
- •Must be healthy non-soft contact lens wearers (neophytes), or experienced contact lens wearers that have not worn their contact lenses for a minimum of 7 days
- •Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle plane
- •The subject must be able to attend study visits at the prescribed visit times and adhere to the study instructions
排除标准
- •Pregnant and/or lactating females by self-report
- •Presence of current LWE on the upper eyelid (>0.5 in height or width)
- •Has greater than -1.00DC of refractive cylinder
- •Has greater than 1.00D of anisometropia
- •Has clinically significant corneal or conjunctival staining that would prevent contact lens fitting, as assessed with sodium fluorescein dye
- •Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-Johnson Syndrome, etc.) or significant Dry Eye Syndrome
- •Has clinically significant corneal vascularization or central corneal scaring
- •Has active ocular surface infection (e.g. conjunctivitis)
- •Has a positive history of eyelid surgery or trauma
- •Has a positive history of refractive surgery
- •Takes medications that significantly impact contact lens comfort and/or ocular surface health
- •Has taken part in another contact lens or contact lens solution clinical trial within the last 7 days
- •Is unwilling to have eyes photographed or video recorded
结局指标
主要结局
Lid Wiper Epitheliopathy
时间窗: One week post contact lens fitting
Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy.
次要结局
- Lid Wiper Epitheliopathy(2 hours post contact lens fitting)
研究者
Eric R. Ritchey
Assistant Professor
University of Houston