NCT01230554已完成不适用
A Study to Assess the Product Performance of a Daily Disposable Contact Lens
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- Market Research Survey
研究概览
简要总结
The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 38 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must be females of Chinese descent and of legal age and no older than
- •OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
- •Subjects must have clear central corneas and be free of any anterior segment disorders.
- •Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.
排除标准
- •Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- •Subjects who have any systemic disease affecting ocular health.
- •Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Subjects with an active ocular disease or are using any ocular medication.
- •Subjects with any scar or neovascularization within the central 4 mm of the cornea.
- •Subjects who are aphakic or amblyopic.
- •Subjects who have had any corneal surgery (eg, refractive surgery).
- •Subjects who currently wear monovision, multifocal, or toric contact lenses.
研究组 & 干预措施
Prism I
Experimental
Bausch & Lomb daily disposable cosmetic tint contact lens
干预措施: Daily disposable cosmetic tint lens (Device)
结局指标
主要结局
Market Research Survey
时间窗: 1 week
Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor.
次要结局
- Lens Evaluation - Movement(Over all study visits through 1 week)
- Lens Evaluation - Centration(Over all study visits through 1 week)
- Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA).(Over all study visits for 1 week)
研究者
研究点 (2)
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