Clinical Evaluation of the Safety and Efficacy of a New Multifocal Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 主要终点
- Subjective Overall Vision
研究概览
简要总结
The purpose of this study was to demonstrate substantial equivalence of the new DAILIES® AquaComfort Plus® Multifocal (DACP MF) contact lens to the commercially available Focus® DAILIES® Progressives (FDP) contact lens.
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
- Single (Participant)
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.
- •Presbyopic and require a spectacle add of up to and including 3.00 diopters (D).
- •Currently wear soft contact lenses.
- •Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial and comply with the wearing and replacement schedule.
- •Manifest cylinder less than or equal to 1.00 D.
- •Able to achieve best corrected visual acuity (BCVA) of 20/25 or better (Snellen) in each eye at distance (as determined by manifest refraction).
- •Able to achieve distance visual acuity of 20/40 (Snellen) or better in each eye with study lenses and deem subjective vision as satisfactory at time of dispense.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment.
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated.
- •History of corneal or refractive surgery.
- •Biomicroscopy findings greater than Grade 2 at baseline.
- •A pathologically dry eye that precludes contact lens wear.
- •Monocular (only one eye with functional vision).
- •Wear habitual contact lenses on an extended wear schedule (any number of nights of overnight wear on a regular basis).
- •History of intolerance or hypersensitivity to any component of the investigational products.
- •Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days.
- •Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DAILIES® AquaComfort Plus® Multifocal
Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
干预措施: Nelfilcon A multifocal contact lens with comfort additive (Device)
Focus® DAILIES® Progressives
Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
干预措施: Nelfilcon A multifocal contact lens (Device)
结局指标
主要结局
Subjective Overall Vision
时间窗: Up to Day 30
The participant was instructed to, "Please rate the aggregate of distance, intermediate, and near vision quality. Fill in the circle below the number that indicates your selection. Rate eyes together, marking only 1 circle for both eyes. Higher numbers mean better vision." The response was recorded on a continuous scale from 1-10 (1=poor, 10=excellent).
次要结局
- Binocular Snellen Visual Acuity (VA) at Near (40cm) With Study Lenses(Up to Day 30)
- Binocular Snellen Visual Acuity (VA) at Distance With Study Lenses(Up to Day 30)