Evaluation of Visual Performance With a Multifocal High ADD Soft Contact Lens Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 主要终点
- High Contrast Visual Acuity (HCVA) Near Monocular
研究概览
简要总结
The purpose of this study is to evaluate the visual performance of a new multifocal High ADD contact lens compared to the currently-marketed AIR OPTIX® AQUA MULTIFOCAL (AOAMF) High ADD Contact Lens.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an Informed Consent document;
- •Presbyopic and require at least 2.25 diopters (D) spectacle ADD power;
- •Current or previous soft contact lens wearer;
- •Not able to achieve monocular near visual acuity (VA) 0.2 logarithm of the Minimum Angle of Resolution (logMAR) [Early Treatment of Diabetic Retinopathy Study (ETDRS)] or better in each eye with AIR OPTIX® AQUA Multifocal (AOAMF) High ADD Contact Lenses;
- •Willing and able to wear multifocal contact lenses in both eyes within the available range of powers for this trial;
- •Manifest cylinder less than or equal to 1.00 D;
- •Able to achieve best corrected visual acuity (BCVA) of 20/25 or better in each eye at distance (as determined by manifest refraction);
- •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, as determined by the investigator;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator; or any use of topical ocular medications that would require instillation during contact lens wear;
- •Any history of herpetic keratitis;
- •History of corneal or refractive surgery, irregular cornea or unilateral pseudophakia;
- •Biomicroscopy findings (except for corneal vascularization) that are moderate (Grade 3) or severe (Grade 4);
- •Corneal vascularization that is mild (Grade 2) or higher;
- •A pathologically dry eye that precludes contact lens wear;
- •Monocular (only 1 eye with functional vision);
- •Anisometropia ≥ 1.50 D (contact lens distance prescription);
- •Clinically significant (> 1 millimeter) anisocoria;
- •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 within the previous 30 days;
- •Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
- •Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the study lenses or affect the results of this study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
New MF, then AOAMF
Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour.
干预措施: Lotrafilcon B multifocal contact lenses (new) (Device)
New MF, then AOAMF
Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally (in both eyes) for about 1 hour.
干预措施: Lotrafilcon B multifocal contact lenses (Device)
AOAMF, then New MF
Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour.
干预措施: Lotrafilcon B multifocal contact lenses (Device)
AOAMF, then New MF
Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally (in both eyes) for about 1 hour.
干预措施: Lotrafilcon B multifocal contact lenses (new) (Device)
结局指标
主要结局
High Contrast Visual Acuity (HCVA) Near Monocular
时间窗: Day 1, 10 minutes after lens insertion, each product
Visual Acuity (clarity or sharpness of vision) was measured at high contrast level. HCVA was assessed monocularly (each eye separately) at 40 centimeters using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart and measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower logMAR value indicates better visual acuity. Both eyes contributed to the analysis.
次要结局
- Low Contrast Visual Acuity (LCVA) Distance Monocular(Day 1, 10 minutes after lens insertion, each product)
- HCVA Distance Monocular(Day 1, 10 minutes after lens insertion, each product)
- HCVA Intermediate Monocular(Day 1, 10 minutes after lens insertion, each product)