DAILIES® AquaComfort Plus® MF - Comparative Assessment of Visual Performance Using Objective Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
研究概览
简要总结
The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.
详细描述
In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.
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
- Single (Investigator)
入排标准
- 年龄范围
- 41 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
- •Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
- •Requiring lenses within the power range of both study contact lenses to be fitted
- •Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
- •Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
- •Acceptable fit with both study contact lenses
- •Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Current multifocal contact lens wearer
- •Current monovision wearer or failed attempt with monovision
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
- •Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
- •Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
- •Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
- •History of herpetic keratitis, ocular surgery or irregular cornea
- •Prior refractive surgery (e.g. LASIK, PRK, etc)
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens
- •Habitually uncorrected anisometropia >2.00D
- •Clinically significant anisocoria
- •Participation in any clinical trial within 30 days of the enrollment visit
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
Area for Each Region (Near and Intermediate) Under the Mean Defocus Curve (AUC) at High Luminance
时间窗: Day 5, each product
Visual acuity was measured with contact lenses in place using an Early Treatment Diabetic Retinopathy Study (ETDRS) high contrast logMAR chart under well-lit conditions. Lenses of different spherical powers (+2.00 diopter to -5.00 diopter) were placed in front of the eyes to produce varying levels of defocus, and logMAR acuity at each defocus value was recorded. The area under the defocus curve (AUC) was calculated via the trapezoidal rule for the entire study population by treatment using a 0.3 logMAR threshold for intermediate from -2.00 D (50cm) to -0.50 D (2m) and near from -4.00 D (25cm) to -2.00 D (50cm). A higher value indicates a bigger area of focus. This outcome measure was prespecified for monovision and DACP MF.
次要结局
未报告次要终点