The Evaluation of Silicone Hydrogel Lens Wettability With Marketed Lens Care Solutions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- Ex Vivo Contact Angle
研究概览
简要总结
The purpose of this study is to assess ex vivo wettability of a commonly prescribed silicone hydrogel (SiH) contact lens with three marketed contact lens care solutions.
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
- •18 years of age
- •Soft contact lens wear on a daily wear basis
- •Able to wear lenses at least 8 hours
- •Generally healthy with normal ocular health
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Use of additional lens cleaners
- •Known sensitivities to any ingredient in any of the study products
- •History of ocular surgery/trauma within the last 6 months
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
Synergi, then Biotrue, then OTE
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Biotrue multipurpose solution (Device)
Synergi, then Biotrue, then OTE
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Sauflon Synergi multipurpose solution (Device)
Synergi, then Biotrue, then OTE
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: OTE Elements multipurpose solution (Device)
Synergi, then Biotrue, then OTE
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Silicone hydrogel contact lenses (Acuvue Advance) (Device)
Synergi, then OTE, then Biotrue
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Biotrue multipurpose solution (Device)
Synergi, then OTE, then Biotrue
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Sauflon Synergi multipurpose solution (Device)
Synergi, then OTE, then Biotrue
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: OTE Elements multipurpose solution (Device)
Synergi, then OTE, then Biotrue
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Silicone hydrogel contact lenses (Acuvue Advance) (Device)
Biotrue, then OTE, then Synergi
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Biotrue multipurpose solution (Device)
Biotrue, then OTE, then Synergi
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Sauflon Synergi multipurpose solution (Device)
Biotrue, then OTE, then Synergi
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: OTE Elements multipurpose solution (Device)
Biotrue, then OTE, then Synergi
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Silicone hydrogel contact lenses (Acuvue Advance) (Device)
Biotrue, then Synergi, then OTE
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Biotrue multipurpose solution (Device)
Biotrue, then Synergi, then OTE
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Sauflon Synergi multipurpose solution (Device)
Biotrue, then Synergi, then OTE
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: OTE Elements multipurpose solution (Device)
OTE, then Biotrue, then Synergi
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Sauflon Synergi multipurpose solution (Device)
OTE, then Biotrue, then Synergi
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: OTE Elements multipurpose solution (Device)
Biotrue, then Synergi, then OTE
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Silicone hydrogel contact lenses (Acuvue Advance) (Device)
OTE, then Biotrue, then Synergi
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Biotrue multipurpose solution (Device)
OTE, then Biotrue, then Synergi
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Silicone hydrogel contact lenses (Acuvue Advance) (Device)
OTE, then Synergi, then Biotrue
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Biotrue multipurpose solution (Device)
OTE, then Synergi, then Biotrue
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Sauflon Synergi multipurpose solution (Device)
OTE, then Synergi, then Biotrue
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: OTE Elements multipurpose solution (Device)
OTE, then Synergi, then Biotrue
Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
干预措施: Silicone hydrogel contact lenses (Acuvue Advance) (Device)
结局指标
主要结局
Ex Vivo Contact Angle
时间窗: 8 hours
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 Dynamic Contact Angle Instrument was used to observe, record, and calculate contact angle measurements. The measurements from the right eye and left eye were averaged. A lower contact angle measurement indicates a more wettable lens.
次要结局
- Subjective Comfort(8 hours)
- Corneal Staining Type(8 hours)
- Corneal Staining Extent(8 hours)