A Clinical Comparison of Three Contact Lens Care Systems and Their Effect on Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- End of day comfort
研究概览
简要总结
The purpose of this study was to evaluate the clinical performance of three differing contact lens care solutions when used in conjunction with three contact lenses.
详细描述
This study was conducted as three separate studies based on the contact lens brand dispensed. In each study, the contact lens was evaluated in conjunction with three solutions: Opti-Free Replenish, ReNu MultiPlus, and Clear Care. The total enrollment number of 75 represents a combined enrollment of the three studies, with some subjects participating in more than one study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Signed informed consent.
- •Adapted contact lens wearer for at least one month.
- •Spherical prescription range between +6.00 to -8.00 diopters.
- •Astigmatism of less than or equal to 1.00 diopter in at least one eye.
- •Normal eyes with no evidence of abnormality or disease.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Rigid Gas Permeable (RGP) contact lens wear in last 30 days.
- •Concurrent ocular medication, systemic illness, or medical treatment that will affect ocular physiology, lens performance, or vision.
- •Corneal infiltrates, scarring, or neovascularization within central 4 millimeters of cornea.
- •Eye injury or surgery within 8 weeks prior to study.
- •Aphakia, amblyopia, abnormal lacrimal secretions, ocular irritation, keratoconus, corneal irregularity, pregnancy, lactating, planning to become pregnant during the study, and participation in a concurrent clinical trial.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
End of day comfort
时间窗: 2 weeks
As assessed by the subject as a measure of the comfort of the contact lenses at the end of an average day. End of day comfort is recorded on an 11-point scale where 0=poor and 10=excellent.
Bulbar hyperemia
时间窗: 2 weeks
Bulbar hyperemia is the injection (or redness) of the blood vessels in the tissues overlaying the white of the eye. Bulbar hyperemia is measured on a 0-4 scale, with 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Half-grades are allowed.
Corneal staining type
时间窗: 2 weeks
An ophthalmic dye is used to highlight dead or degenerated corneal epithelial cells. The type of staining is measured over the five sectors of the cornea on a 0-4 scale, where 0=none, 1=micropunctate, 2=macropunctate, 3=coalesced macropunctate, and 4=patch (1mm). The five sectors are averaged to give a single score.
Upper palpebral roughness
时间窗: 2 weeks
The roughness of the inner lining of the upper eyelid is measured on a 0-4 scale, where 0=uniform appearance, 1=trace, 2=mild, 3=moderate, and 4=severe. Half grades are allowed.
High contrast visual acuity
时间窗: 2 weeks
High contrast visual acuity is a measure of the clearness of vision with full room illumination. Visual acuity is measured with a computer-generated, high contrast logMAR (logarithm minimum angle of resolution) chart.
Modulus
时间窗: 2 weeks
Modulus is a measure of the stiffness of a contact lens material. Modulus is determined from the slope of the stress-strain curve created during tensile tests conducted on a sample of the material. Modulus is measured in mega Pascals (MPa). A higher modulus indicates a stiffer contact lens.
次要结局
未报告次要终点