Multicenter, Single-masked, Randomized, Parallel, Controlled Study to Compare Senofilcon A Contact Lenses to Currently Used Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 11
- 主要终点
- Corneal Staining
研究概览
简要总结
The purpose of the study is to evaluate the possible benefits of second generation silicone hydrogel contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must:
- •be existing soft contact lens wearers of the study control lenses
- •require a distance visual correction in both eyes
- •have a contact lens spherical distance requirement between -1.00 diopters (D) and -8.00D in both eyes
- •have astigmatism less than or equal to 1.00D in both eyes
- •be able to wear lenses available for this study
- •be corrected to a visual acuity of 6/9 (20/30) or better in each eye
- •have normal eyes with no evidence of abnormality or disease
排除标准
- •Subject are excluded for the following reasons:
- •monovision corrected
- •worn lenses extended wear in the last 3 months.
- •require concurrent ocular medication
- •grade 3 or 4 abnormalities
- •grade 3 corneal staining in more than two regions
- •anterior ocular surgery
- •any other ocular surgery or injury within 8 weeks prior to study enrollment
- •abnormal lachrymal secretions
- •pre-existing ocular irritation that would preclude contact lens fitting
- •corneal irregularities
- •Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in past 12 weeks
- •any systemic illness which would preclude contact lens wear
- •infectious or immunosuppressive disease
- •pregnancy or lactating, or planning pregnancy at time or enrollment
- •participating in a concurrent clinical study or within last 60 days
- •allergy to the standardized study care solution
研究组 & 干预措施
senofilcon A
contact lens
干预措施: senofilcon A (Device)
lotrafilcon B
contact lens
干预措施: lotrafilcon B (Device)
balafilcon A
contact lens
干预措施: balafilcon A (Device)
methafilcon A
contact lens
干预措施: methafilcon A (Device)
vifilcon A
contact lens
干预措施: vifilcon A (Device)
结局指标
主要结局
Corneal Staining
时间窗: 4 weeks
Subject distribution according to corneal staining with fluorescein scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Limbal Hyperemia (Redness)
时间窗: 4 weeks
Subject distribution according to limbal hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Bulbar Hyperemia (Redness)
时间窗: 4 weeks
Subject distribution according to bulbar hyperemia scale in each eye during the 4-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Limbal Hyperemia (Redness)
时间窗: 2 weeks
Subject distribution according to limbal hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Bulbar Hyperemia (Redness)
时间窗: 2 weeks
Subject distribution according to bulbar hyperemia scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
Corneal Staining
时间窗: 2 weeks
Subject distribution according to corneal staining with fluorescein scale in each eye during the 2-week Follow-up Visit. For this scale, 0 is lowest and 4 is greatest. If present in at least one eye, then it is counted.
次要结局
未报告次要终点