NCT00382603已完成不适用
Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses in Symptomatic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 362
- 试验地点
- 2
- 主要终点
- Efficacy:
研究概览
简要总结
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic for contact lens related discomfort at the end of the lens wearing day.
- •Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
- •Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
- •Successful lens wear for at least 4 hours per day.
- •Vision correctable to 20/
- •Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
- •No corneal surgery within the past 12 months.
- •No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
- •No over-the-counter or prescription ocular medication.
- •No enrollment in another clinical study within 30 days prior to enrollment.
排除标准
- 未提供
结局指标
主要结局
Efficacy:
Ocular Comfort and Symptom Scales
Subject Questions/Subject Likert Questionnaire
Safety:
Slit-lamp Findings - Cornea: Edema, Neovascularization, Infiltrates; Injection, Tarsal Abnormalities and Other Complications
Adverse Events
次要结局
- Corneal Fluorescein Staining (Type and Area)
- Lens Surface Evaluation (Lens Deposit and Lens Wettability)
- Lens Replacement Incidence and Causality
- Corrected Visual Acuity with Study Lenses (Snellen)
- Rewetting Drop Frequency
- Lens Removal Frequency
- Average Lens Wearing Time
- Average Uncomfortable Lens Wearing Time
研究者
研究点 (2)
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