Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 387
- 主要终点
- Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"
研究概览
简要总结
The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.
详细描述
Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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.
- •Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.
- •Willing to wear contact lenses on a daily wear basis for the duration of the study.
- •Currently using a multi-purpose solution, as specified in protocol.
- •Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit
- •Willing to follow the study procedures and visit schedule.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses.
- •Currently using any Opti-Free brand of multi-purpose solution.
- •Must wear contact lenses on an extended wear (overnight) basis during the study.
- •Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products.
- •Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.
- •Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit
- •Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit
- •Any abnormal ocular condition observed during the Visit 1 slit-lamp examination.
- •Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit
- •Ocular surgery within the 12 months prior to Visit
- •Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions.
- •Participation in any clinical study within 30 days of Visit
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Air Optix/OFPM
Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
干预措施: Lotrafilcon B contact lenses (Device)
Air Optix/OFPM
Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
干预措施: OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) (Device)
Acuvue Oasys/Habitual MPS
Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
干预措施: Senofilcon A contact lenses (Device)
Acuvue Oasys/Habitual MPS
Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
干预措施: Habitual Multi-Purpose Solution (MPS) (Device)
结局指标
主要结局
Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"
时间窗: Day 30; after 4 hours of lens wear
Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.
次要结局
未报告次要终点