Clinical Evaluation of a Daily Disposable Contact Lens in Symptomatic Weekly/Monthly Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 主要终点
- Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
研究概览
简要总结
The purpose of this study was to evaluate the reduction of contact lens-related dryness symptoms when symptomatic weekly/monthly contact lens wearers were switched to DAILIES® AquaComfort Plus® lenses for a two-week period using composite scores on the Contact Lens Dry Eye Questionnaire (CLDEQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Currently wearing weekly/monthly, silicone hydrogel or traditional hydrogel soft contact lenses at least 8 hours per day and 5 days a week during the past 6 months.
- •Identified as symptomatic using a baseline screening questionnaire.
- •Requires vision correction in both eyes with a contact lens prescription as follows: sphere powers between -0.50 and -10.00 diopter (D) and cylinder powers </= 0.75D and no ADD correction.
- •Able to achieve visual acuity (VA) of at least 6/7.5 in each eye with study lenses in the available parameters.
- •Willing to wear study lenses for at least 8 hours/day and at least 5 days/week and discard the lenses at the end of the day and replace lenses every day with a new fresh pair.
- •Willing and able to follow instructions and maintain the appointment schedule.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Neophytes and current wearers of daily disposable contact lenses.
- •Requires monovision correction.
- •Any systemic or ocular disease or disorder (refractive disorder allowed) complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- •A history of ocular surgery/trauma within the last 6 months.
- •Unwilling to discontinue mechanical eyelid therapy or eyelid scrubs within 14 days of enrollment and continuing during the study.
- •Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Change From Baseline in Contact Lens-Related Dryness Symptoms at Week 1 and Week 2
时间窗: Baseline, Week 1, Week 2
Contact lens symptoms were evaluated using the Contact Lens Dry Eye Questionnaire (CLDEQ). Subjects rated 8 common contact lens-related ocular surface dryness symptoms at Baseline, Week 1, and Week 2 using a 5-point scale (1=never or not at all intense, 5=constantly or very intense). A scoring algorithm was used to calculate a composite score for each visit for all symptoms (-6.5 to 10). A higher composite score would indicate more contact lens related dry eye and a lower score, less contact lens related dry eye.
次要结局
未报告次要终点