NCT02750813已完成不适用
ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®: Clinical Comparison in a Symptomatic Population
Alcon, a Novartis Company2 个研究点 分布在 1 个国家目标入组 252 人开始时间: 2016年4月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 2
- 主要终点
- Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
研究概览
简要总结
The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Must sign informed consent form;
- •Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
- •Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
- •Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
- •Cylinder equal or lower than -0.75D in both eyes;
- •Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
- •Can be successfully fitted with both study lenses at Visit 1;
- •Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Fitted with monovision;
- •Prior refractive surgery;
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Pregnant or lactating;
- •Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- •Participation in any clinical study within 30 days of Visit 1;
- •Current DT1 or AO1D lens wearer;
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
时间窗: Day 14, each product
Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
次要结局
- Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14(Day 14, each product)
研究者
研究点 (2)
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