Subjective and Conjunctival Response to Edge Design of Different Silicone Hydrogels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Circumlimbal Conjunctival Staining (CCS)
研究概览
简要总结
The purpose of this study was to evaluate the effect of different contact lens edge designs on the circumlimbal conjunctiva.
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
- Double (Participant, 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
- •Minimum age of 18 years old
- •Adapted contact lens wearer
- •Sign informed consent
- •Normal eyes with the exception of the need for visual correction
- •Astigmatism less than or equal to -0.75 diopter
- •Spherical prescription range between -10.00 and +6.00 diopters
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Any known sensitivity to the test articles used in the study
- •Monocular vision
- •Lid or conjunctival infections or abnormalities
- •Conjunctival staining greater than Grade 1
- •Corneal staining greater than Grade 2
- •Corneal edema or opacifications
- •Any previous corneal surgery
- •Recent significant changes in visual acuity
- •Ocular disease that contraindicates contact lens wear
- •Tarsal abnormalities greater than Grade 2
- •Any ophthalmic medication
- •Any systemic medication or condition that might affect the subject's participation in the study
- •Chronic upper respiratory infections or colds
- •Pregnancy or planning to become pregnant
- •Lactation
- •Seasonal allergies
- •Known infections or immunosuppressive disease
- •Participation in other studies
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Acuvue Oasys
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Senofilcon A contact lens (Acuvue Oasys) (Device)
Acuvue Oasys
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Contact lens care system (EasySept) (Device)
Acuvue 2
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Contact lens care system (EasySept) (Device)
Biofinity
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Comfilcon A contact lens (Biofinity) (Device)
Biofinity
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Contact lens care system (EasySept) (Device)
Air Optix
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Lotrafilcon B contact lens (Air Optix) (Device)
Air Optix
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Contact lens care system (EasySept) (Device)
PureVision
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Balafilcon A contact lens (PureVision) (Device)
PureVision
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Contact lens care system (EasySept) (Device)
Acuvue 2
One of five contact lens brands worn bilaterally on a daily wear basis in randomized order for 10 days each.
干预措施: Etafilcon A contact lens (Acuvue 2) (Device)
结局指标
主要结局
Circumlimbal Conjunctival Staining (CCS)
时间窗: After 10 days of wear
次要结局
未报告次要终点