NCT01100411已完成不适用
Changes in Invitro and ex Vivo Lens Metrology With Experienced Daily Wear Contact Lens Wearers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Lens Geometry
研究概览
简要总结
The purpose of this study is to evaluate changes in contact lens geometry after lens wear
详细描述
The purpose of this study is to evaluate changes invitro and ex vivo in contact lens geometry in daily lens wear
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
- None
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
- •• Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent;
- •Be at least 18 years old;
- •Willing to comply with the wearing and clinical trial visit schedule as directed by the investigator;
- •Have ocular health findings considered to be "normal" and which would not prevent the participant from safely wearing contact lenses;
- •Has vision correctable to at least 6/12 (20/40) or better at distance in each eye with contact lenses;
- •Be experienced at wearing contact lenses.
排除标准
- •• Any pre-existing ocular irritation, injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids that would preclude contact lens fitting and safe wearing of contact lenses;
- •Any systemic disease that adversely affects ocular health
- •An active corneal infection or any active ocular disease that would affect wearing of contact lenses;
- •Use of any topical ocular medication during trial with the exception of saline drops ;
- •Use of or a need for any systemic medication or topical medications which may alter normal ocular findings/are known to affect a participant's ocular health/physiology or contact lens performance
- •Eye surgery within 12 weeks immediately prior to enrolment for this trial;
- •Previous corneal refractive surgery;
- •Contraindications to contact lens wear;
- •Participated or currently enrolled in another clinical trial that may have affected vision or ocular physiology within the previous 2 weeks;
- •Be pregnant (formal testing of pregnancy is not required. A participant's verbal report is sufficient);
- •Worn soft contact lenses 2 calendar days or rigid gas permeable/ orthokeratology lenses 7 calendar days prior.
结局指标
主要结局
Lens Geometry
时间窗: 1 week
次要结局
- Corneal Shape(1 week)
- Conjunctival Staining(1 week)
研究者
研究点 (2)
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