NCT01959178已完成不适用
A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Mean Visual Acuity
研究概览
简要总结
This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add soft contact lenses when used among currently adapted soft contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- 否
入选标准
- 未提供
排除标准
- •Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- •Participated in any drug or device clinical investigation (within 14 days) prior to entry into this study and/or during the period of study participation.
- •Women of childbearing potential if one of the following: pregnant, plans to become pregnant during study, is breast-feeding.
- •Any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible.
- •Any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
- •Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Anisometropia (spherical equivalent) of greater than 2.00 D.
- •Amblyopic.
- •Allergic to any component in the study care products.
- •Meet any of the following criteria:
- •Ophthalmologist, OD, Optician, Ophthalmologist's Assistant/Technician
- •employee of a market research firm
- •employee of manufacturer of contact lens or contact lens care products
- •Ocular astigmatism of greater than 1.00 D in either eye.
- •Have had any corneal surgery (ie, refractive surgery).
- •Toric contact lens wearer.
- •Have worn gas permeable (GP) contact lenses within the last 30 days or PMMA lenses within the last 3 months.
- •Have an active ocular disease or are using any ocular medication.
- •Have any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health during the course of the study.
- •Using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
结局指标
主要结局
Mean Visual Acuity
时间窗: At 1 Week follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
次要结局
- Symptoms/Complaints(At 1 Week follow up)
研究者
研究点 (2)
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