NCT01951573已完成不适用
Delefilcon A Multifocal Plus Power Lens Design Evaluation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
研究概览
简要总结
The purpose of this study is to demonstrate non-inferiority of a new daily disposable multifocal contact lens in plus powers against the commercially available AIR OPTIX® AQUA MULTIFOCAL (AOAMF) lens in high contrast/high illumination (HC/HI) near visual acuity (VA).
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
- •Subjects with normal eyes who are not using any ocular medication.
- •Must sign the Informed Consent document.
- •Habitual lens power within the range available for the study lenses (+1.00 to +3.50 diopters(D)).
- •Manifest cylinder less than or equal to 0.75D.
- •Best corrected distance VA greater than or equal to 20/25 in each eye.
- •Existing soft contact lens (CL) wearers who wear contact lenses in both eyes at least 5 days per week.
- •Presbyopic with a spectacle addition (ADD) >0.50D and <2.75D.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular disease, inflammation, or abnormality that contraindicates CL wear.
- •Any use of systemic or ocular medications for which CL wear could be contraindicated.
- •History of herpetic keratitis.
- •History of refractive surgery or irregular cornea.
- •A clinically significant dry eye that precludes CL wear.
- •Participation of the subject in a clinical study (including CL or CL care product) within the previous 30 days.
- •Monocular (only 1 eye with functional vision).
- •History of intolerance or hypersensitivity to any component of the test articles.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
High Contrast/High Illumination (HC/HI) Binocular Visual Acuity (VA) at Near
时间窗: Dispense (Day 1), Hour 9
Near VA was assessed binocularly (both eyes together) at 40 centimeters, with over-refraction (OR), if necessary, and measured in logMAR units (logarithm of the minimum angle of resolution). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity.
次要结局
- HC/HI Binocular VA at Distance(Dispense (Day 1), Hour 9)
- Over-refraction (OR) Monocular at Distance(Dispense (Day 1), Hour 9)
研究者
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