Clinical Study of CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 主要终点
- Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
研究概览
简要总结
The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE® multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and experiencing symptoms of dryness.
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
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an informed consent document;
- •Current adapted two-week/monthly replacement soft contact lens wearers (at least 2 months) with symptoms of contact lens induced dryness;
- •Near spectacle add of +0.50 or greater;
- •Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance;
- •Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, and attend all study visits;
- •Currently (at least 2 months) using a non-HYDRAGLYDE® containing multi-purpose solution (OPTI-FREE® PureMoist® is excluded) to care for lenses;
- •Use of digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) for 20 consecutive minutes at least twice a week and willing to continue the same pattern for the duration of the study;
- •Other protocol-specific inclusion criteria may apply.
排除标准
- •Extended wear contact lens wearer (sleeps in lenses 1 or more nights per week);
- •Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the investigator, including use of any topical ocular medications that would require instillation during contact lens wear;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Known sensitivity to any ingredients in CLEAR CARE® PLUS (CCP);
- •Prior refractive surgery;
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Pathological dry eye that precludes contact lens wear;
- •Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- •Participation in any clinical study within 30 days of Visit 1;
- •Currently using or have not discontinued Restasis®, Xiidra® or a topical steroid within the past 7 days;
- •Other protocol-specific exclusion criteria may apply.
研究组 & 干预措施
CCP, then HMPS
3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
干预措施: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix (Device)
CCP, then HMPS
3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
干预措施: Habitual Multi-Purpose Contact Lens Solution (Device)
CCP, then HMPS
3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 1, followed by subject's habitual multi-purpose contact lens solution (HMPS) in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
干预措施: Habitual Contact Lenses (Device)
HMPS, then CCP
Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
干预措施: Habitual Multi-Purpose Contact Lens Solution (Device)
HMPS, then CCP
Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
干预措施: 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix (Device)
HMPS, then CCP
Subject's habitual multi-purpose contact lens solution in Period 1, followed by 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix contact lens solution in Period 2. Each product used daily per packaging instructions with subject's habitual contact lenses for approximately 30 cleaning and disinfection cycles.
干预措施: Habitual Contact Lenses (Device)
结局指标
主要结局
Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Score at Day 30
时间窗: Day 30, each product
CLDEQ-8 score (assessment of contact lens discomfort) was obtained by adding the numerical responses to each of 8 items. Individual scales ranged from 0-4, 0-5, and 1-6, with a resultant overall score from 1 minimum to 37 maximum. A lower CLDEQ-8 score indicates less frequent or less intense symptoms.
次要结局
未报告次要终点