Evaluation of the Effectiveness of Two Marketed Multi-Purpose Solutions for Silicone Hydrogel Contact Lenses - Study 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 主要终点
- Subjective Lens Wear Comfort
研究概览
简要总结
The purpose of this study was to evaluate the performance of Opti-Free® PureMoist® Multi-purpose Disinfecting Solution (MPDS) compared to AMO RevitaLens OcuTec® MPDS (US brand name)/COMPLETE RevitaLens (Europe brand name) in silicone hydrogel contact lens wearers.
详细描述
In this 2-period crossover study, eligible participants were randomized to either Opti-Free® PureMoist MPDS or RevitaLens MPDS in Period 1 for use with their habitual contact lenses, after which they switched to the alternate solution in Period 2. Each period was 30 days in length. A 2-day washout period during which participants refrained from using a multi-purpose contact lens solution preceded Period 1 and Period 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Wear single vision sphere silicone hydrogel contact lenses (CooperVision™ Biofinity®, Alcon® Air Optix® Aqua, Bausch+Lomb® PureVision™ or ACUVUE® Oasys™) on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for at least 1 month prior to Visit 1;
- •Willing to wear lenses on a daily wear basis (a minimum of 8 hours per day, 5 days a week) for the duration of the study, and wear lenses for 16 hours on 2 days during the study;
- •Must have habitually used a biguanide preserved multi-purpose solution (other than RevitaLens) for at least 30 days prior to Visit 1;
- •Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses at Visit 1;
- •Have access, capability and willingness to review and answer text messages;
- •Read, sign, and date IRB/IEC approved informed consent and privacy document before enrollment;
- •Willing to follow the study procedures and visit schedule;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Need to wear lenses on an extended wear (i.e overnight) basis during the study;
- •Known sensitivity or intolerance to biguanide, polyquaternium-1 (POLYQUAD), or ALDOX preserved lens care products;
- •Monocular (only one eye with functional vision) or fit with only one lens;
- •Wearing toric or multifocal contact lenses or fit with monovision;
- •Use of additional lens care products other than a biguanide preserved multi-purpose solution such as daily or enzyme cleaners within the 1 week prior to Visit 1;
- •Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of rewetting drops, within 7 days prior to Visit 1;
- •Abnormal ocular condition observed during the Visit 1 slit-lamp examination;
- •Current or history of ocular infections or severe inflammation within 6 months prior to Visit 1;
- •Ocular surgery within the 12 months prior to Visit 1;
- •Participation in any other clinical trial within 30 days of enrollment;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Subjective Lens Wear Comfort
时间窗: Day 30
Lens wear comfort was assessed by the participant on a 5-point Likert scale. The participant was instructed to select a single response to the statement, "When I use this solution, I can comfortably wear my lenses," with 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
次要结局
未报告次要终点