NCT00520689已完成3 期
Multipurpose Solution Compatibility With a Silicone Hydrogel Lens
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- To see if there are any effects on the cornea when using each contact lens/solution combination.
研究概览
简要总结
The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft).
详细描述
The purpose of this study is to verify the compatibility of a silicone hydrogel lens when used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®, Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 17 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is at least 17 years old and has full legal capacity to volunteer
- •Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers
- •Is willing and able to follow instructions and maintain the study appointment schedule
- •Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction
- •Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D)
- •Has clear corneas and no active ocular disease
- •Has had an ocular examination in the last two years.
- •Has a functional pair of spectacles
- •Is a current soft lens wearer replacing their lenses at least monthly
- •Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fitted with the study lens
- •Has astigmatism less than or equal to -1.00DC
- •Agrees to wear the study lenses on a daily wear basis
排除标准
- •A person will be excluded from the study if he/she:
- •Has any signs or symptoms of dry eye
- •Has any clinically significant blepharitis
- •Has undergone corneal refractive surgery
- •Has any systemic disease affecting ocular health
- •Is using any systemic or topical medications that may affect ocular health
- •Is pregnant or lactating
- •Is participating in any other type of clinical or research study
- •Currently wears daily disposable lenses
- •Currently wears lenses on a continuous or extended wear basis
- •Is unable to successfully wear contact lenses without routinely using rewetting drops
结局指标
主要结局
To see if there are any effects on the cornea when using each contact lens/solution combination.
时间窗: Over 2 days
次要结局
- To quantify comfort and vision ratings with each lens/solution combination.(over 2 days)
研究者
研究点 (2)
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