Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 187
- 主要终点
- Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
研究概览
简要总结
The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.
详细描述
This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.
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
- Double (Participant, Outcomes Assessor)
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
- •Sign Informed Consent document.
- •Severe lid wiper epitheliopathy (upper lid) in either eye.
- •Currently wearing spherical daily disposable soft contact lenses or daily wear soft contact lenses in both eyes with at least 3 months of contact lens wearing experience.
- •Symptomatic as determined by the SPEED questionnaire.
- •Willing to follow visit schedule.
- •Habitual contact lens power with the range of -1.00 to -6.00 diopters (D) with best corrected distance visual acuity greater than or equal to 20/25 in each eye.
- •Astigmatism less than or equal to 0.75D.
- •Possess spectacles which provide visual acuity of at least 20/25 in each eye.
- •Willing and able to complete daily diaries.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Eye injury within 12 weeks immediately prior to enrollment.
- •Any ocular condition that would contraindicate contact lens wear.
- •Any use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator.
- •Currently wearing toric or multifocal soft contact lenses.
- •Participation in a clinical study (including contact lens or contact lens care product) within the previous 30 days.
- •Routinely sleeps in lenses for at least 1 night per week.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
时间窗: Baseline, Week 2
LWE was measured by slit lamp evaluation of fluorescein and lissamine green staining of the upper eyelid. LWE was graded on a scale from 0 to 3, where 0=none and 3=severe. The percent of eyes experiencing at least a 1 grade reduction in LWE (from baseline) at the 2-week visit was compared between groups. One eye (study eye) contributed to the analysis.
Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
时间窗: Baseline, Week 2
This outcome measure was not evaluated since primary efficacy was not demonstrated.
次要结局
- Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks(Baseline, Week 2)