Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 8
- 主要终点
- Corneal Staining
研究概览
简要总结
To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to wear study lenses in parameters available
- •Non-presbyopes between the ages of 18-45
- •Understand and sign informed consent
- •Willing to follow the protocol
- •Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses
- •Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)
- •Adapted soft contact lens wearer
- •Swims no more than once a week
- •Has a wearable pair of spectacles.
排除标准
- •Any ocular or systemic disorder which may contraindicate contact lens wear
- •Any topical ocular medication
- •Corneal refractive surgery
- •Corneal distortion from hard CL wear or keratoconus
- •Pregnant or lactating
- •Grade 2 or worse slit lamp signs
- •Infectious disease
- •Previous clinical study within 2 weeks
- •Don't agree to participate
- •Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks
- •Previous adverse effects that contraindicate extended lens wear.
- •Self-reported symptoms of itchiness or scratchiness with habitual lenses.
研究组 & 干预措施
senofilcon A toric bilaterally
senofilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
干预措施: senofilcon A toric contact lens (Device)
balafilcon A toric bilaterally
balafilcon A lenses worn daily bilaterally (in both eyes) for 3 months, replaced weekly.
干预措施: balafilcon A toric contact lens (Device)
senofilcon A/balafilcon A contralaterally
senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
干预措施: senofilcon A toric contact lens (Device)
senofilcon A/balafilcon A contralaterally
senofilcon A lens worn in one eye and balafilcon A lens worn in the other eye (contralaterally), daily for 3 months, replaced weekly.
干预措施: balafilcon A toric contact lens (Device)
结局指标
主要结局
Corneal Staining
时间窗: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Limbal Redness
时间窗: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Bulbar Redness
时间窗: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
Tarsal Roughness
时间窗: at 3 months of lens wear (period 1)
Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.
次要结局
未报告次要终点