CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Distance LogMAR Visual Acuity
研究概览
简要总结
A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.
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
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45 years or more
- •Spectacle or soft contact lens wearer
- •Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D
- •Best spectacle corrected visual acuity of 6/9 or better in each eye
- •Willingness to adhere to the instructions set forth in the clinical protocol
- •Signature of the subject Informed Consent form after review of Information to Participant document.
排除标准
- •Systemic or ocular allergies which might interfere with contact lens wear
- •Systemic disease which might interfere with contact lens wear
- •Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)
- •Use of medication which might interfere with contact lens wear
- •Active ocular infection
- •Use of ocular medication
- •Significant ocular anomaly
- •Presence of two or more corneal scars in either eye
- •Monovision contact lens wearers
- •Pregnancy or lactation
- •Any medical condition that might be prejudicial to the study
- •Participants non-able to give consent or from a vulnerable group
- •Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)
- •Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)
研究组 & 干预措施
Control (sphere) /Test (multi-focal)
Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week.
干预措施: Test (multi-focal) (Device)
Control (sphere) /Test (multi-focal)
Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week.
干预措施: Control (Sphere) (Device)
Test (sphere) /Control (multi-focal)
Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week.
干预措施: Test (multi-focal) (Device)
Test (sphere) /Control (multi-focal)
Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week.
干预措施: Control (Sphere) (Device)
结局指标
主要结局
Distance LogMAR Visual Acuity
时间窗: 7 days post wear
Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m\^2 and 2.5 cd/m\^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m\^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (2.5 cd/m\^2) High Contrast (90%)
Near LogMAR Visual Acuity
时间窗: 7 days post wear
Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m\^2 and 50 cd/m\^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m\^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (50cd/m\^2) High Contrast (90%)
次要结局
未报告次要终点