Comparison of Lens Fit and Lens Power of a New Contact Lens to Two Marketed Contact Lenses in a Population of Soft Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Fit Acceptability
研究概览
简要总结
The purpose of this study is to evaluate the comparability of lens fit and lens power of a new contact lens to the lens fit and lens power of two marketed lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age and no more than 55 years of age.
- •Must sign written informed consent.
- •Optimal spherical equivalent distance correction must be between -1.00 and -6.00 diopters.
- •Have spectacle astigmatism ≤ -0.75 diopter cylinder in both eyes.
- •Must have visual acuity best correctable to 20/25+3 or better for each eye.
- •Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: No evidence of lid abnormality or infection; No conjunctival abnormality or infection; No clinical significant slit lamp findings, (i.e., oedema, staining, scarring, vascularization, infiltrates or abnormal opacities); No other active ocular disease.
- •The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
排除标准
- •Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- •Any previous eye surgery involving the anterior segment.
- •Pre-existing ocular disease that would preclude contact lens fitting.
- •Abnormal lacrimal secretions.
- •Keratoconus or other corneal irregularity.
- •Pregnancy, lactating or planning a pregnancy at the time of enrollment.
- •Participation in any concurrent clinical trial.
- •Subject's habitual contact lens type is toric or multifocal.
- •Require any concurrent ocular medication.
研究组 & 干预措施
galy A Plus/ galy A / seno A
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
干预措施: galy A Plus (Device)
galy A Plus/ galy A / seno A
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
干预措施: seno A (Device)
galy A Plus/ galy A / seno A
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
干预措施: galy A (Device)
galy A Plus / seno A / galy A
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: galy A Plus (Device)
galy A Plus / seno A / galy A
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: seno A (Device)
galy A Plus / seno A / galy A
Pair 1: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: galy A (Device)
galy A / galy A Plus / seno A
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
干预措施: galy A Plus (Device)
galy A / galy A Plus / seno A
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
干预措施: seno A (Device)
galy A / galy A Plus / seno A
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
干预措施: galy A (Device)
galy A / seno A / galy A Plus
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: galy A Plus (Device)
galy A / seno A / galy A Plus
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: seno A (Device)
galy A / seno A / galy A Plus
Pair 1: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 2: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: galy A (Device)
seno A / galy A / glay A Plus
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: galy A Plus (Device)
seno A / galy A / glay A Plus
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: seno A (Device)
seno A / galy A / glay A Plus
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: galy A (Device)
seno A / galy A Plus / galy A
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: galy A Plus (Device)
seno A / galy A Plus / galy A
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: seno A (Device)
seno A / galy A Plus / galy A
Pair 1: seno A- subjects were randomized to receive different base curves for each eye (BC: 8.4 or 8.8).
Pair 2: galy A Plus-subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
Pair 3: galy A -subjects were randomized to receive different base curves for each eye (BC: 8.3 or 8.7).
干预措施: galy A (Device)
结局指标
主要结局
Fit Acceptability
时间窗: after 15 minutes of contact lens wear
Investigator evaluated lens fit using a six point scale: 5-optimal...3-borderline acceptable...2-unacceptable. Percent of eyes in each category will be evaluated.
Lens Centration Acceptance
时间窗: after 15 minutes of contact lens wear
Investigator evaluated as acceptable (centered/slightly decentered) or unacceptable (substantially decentered). Number of eyes in each category will be reported by lens. This is an aggregate reporting of the lenses, combining the different base curves into a category by lens type. This is done per protocol, due to this primary outcome not being stratified by base curve.
Primary Gaze Lens Movement
时间窗: after 15 minutes of contact lens wear
Investigator evaluated as acceptable (minimal or moderate movement) or unacceptable (insufficient or excessive movement). Percent of eyes in each category will be evaluated.
次要结局
- New Lens Power Fit Match to Control Lenses(after 15 minutes of contact lens wear)