Proclear 1-D Multifocal Nondispensing Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Objective Vision Assessments: High Contrast Distance Visual Acuity
研究概览
简要总结
This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.
详细描述
The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 40 and 65 years of age (inclusive)
- •Require a reading addition of +1.25 to +2.50D (inclusive)
- •Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
- •Spectacle cylinder less than or equal to 0.75D in both eyes.
- •Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
- •Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
- •Have a minimum 2 weeks soft contact lens experience
- •Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
- •Able to read, comprehend and sign an informed consent
- •Willing to comply with the wear and study visit schedule
- •Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
- •No gas permeable contact lens wear for 1 month prior to the study
排除标准
- •To be eligible for the study, each candidate must not present with any of the following
- •Any active corneal infection, injury, inflammation, or ocular abnormality
- •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
- •Pregnant or lactating
- •Strabismus/amblyopia
- •Habitually uncorrected anisometropia greater than or equal to 2.00 D
- •Subjects who have undergone corneal refractive surgery
- •Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
研究组 & 干预措施
omafilcon A / PC 1-D MF
omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF)
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
干预措施: omafilcon A / PC 1-D MF (Device)
omafilcon A / PC 1-D MF
omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF)
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
干预措施: lotrafilcon B / Air Optix MF (Device)
lotrafilcon B / Air Optix MF
lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF)
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
干预措施: omafilcon A / PC 1-D MF (Device)
lotrafilcon B / Air Optix MF
lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF)
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
干预措施: lotrafilcon B / Air Optix MF (Device)
结局指标
主要结局
Objective Vision Assessments: High Contrast Distance Visual Acuity
时间窗: After 1 hour of lens wear
Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Objective Vision Assessments: High Contrast Near Visual Acuity
时间窗: After 1 hour of lens wear
Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
Objective Vision Assessments: High Contrast Intermediate Visual Acuity
时间窗: After 1 hour of lens wear
Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
次要结局
- Subjective Overall Vision: High Contrast Distance Visual Quality(After 1 hour of lens wear)
- Subjective Vision Assessments: High Contrast Intermediate Visual Quality(After 1 hour of lens wear)
- Subjective Vision Assessments: High Contrast Near Visual Quality(After 1 hour of lens wear)