NCT01629693已完成不适用
Clinical Evaluation of Two Monthly Replacement Silicone Hydrogel Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 398
- 主要终点
- Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30
研究概览
简要总结
The purpose of this study is to evaluate differences in the comfort at the end of the month between Air Optix® lenses versus Biofinity® lenses in habitual daily wear symptomatic soft contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Must sign written informed consent document.
- •Currently wearing weekly/biweekly or monthly sphere or toric soft contact lenses (NOT including AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity Sphere, Biofinity Toric, or ProClear Toric soft contact lenses) bilaterrally (in both eyes) and have worn these lenses for at least 3 months, daily wear use only (no extended wear).
- •Symptomatic for contact lens-related ocular discomfort at the end of the lens wearing day.
- •Current contact lens prescription within the available parameters of both study products.
- •Able to achieve visual acuity (VA) of at least 6/7.5 (20/25) in each eye with study lenses in the available parameters.
- •Willing to wear study lenses for at least 4 hours/day and at least 5 days/week for the 1 month trial period.
- •Willing and able to follow instructions, study procedures and maintain the appointment schedule.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Neophytes and current wearers of AIR OPTIX Aqua, AIR OPTIX NIGHT & DAY Aqua, AIR OPTIX for Astigmatism, Biofinity sphere, Biofinity Toric, or ProClear Toric soft contact lenses.
- •Any systemic or ocular disease or disorder (refractive disorder allowed and dry eye is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
- •Recent (within 7 days of enrollment) or current ocular infections, active ocular inflammation, glaucoma or preauricular lymphadenopathy.
- •A history of ocular surgery/trauma within the last 6 months.
- •Topical or systemic antibiotics use within 7 days of enrollment.
- •Topical ocular or systemic corticosteroids use within 14 days of enrollment.
- •Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change From Baseline in Likert Response: "I Can Comfortably Wear my Lenses" at Day 30
时间窗: Baseline, Day 30
Overall comfort was assessed by the participant as a response to the questionnaire item 'I can comfortably wear my lenses', using a 10-point Likert scale, with 1=poor and 10=excellent.
次要结局
未报告次要终点
研究者
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