Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 主要终点
- Tear Film Evaporation Rate
研究概览
简要总结
The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.
详细描述
This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Sign an informed consent document;
- •Adapted, current soft contact lens wearer;
- •Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
- •Can be successfully fitted with study lenses;
- •Willing to wear lenses for a minimum of 8 hours prior to each study visit;
- •Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
- •Monocular (only 1 eye with functional vision) or fit with only one lens;
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Known pregnancy and lactation;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Sequence 1
Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Delefilcon A contact lenses (Device)
Sequence 1
Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Narafilcon A contact lenses (Device)
Sequence 1
Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Somofilcon A contact lenses (Device)
Sequence 2
Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Delefilcon A contact lenses (Device)
Sequence 2
Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Narafilcon A contact lenses (Device)
Sequence 2
Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Somofilcon A contact lenses (Device)
Sequence 3
Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Delefilcon A contact lenses (Device)
Sequence 3
Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Narafilcon A contact lenses (Device)
Sequence 3
Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Somofilcon A contact lenses (Device)
Sequence 4
No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Delefilcon A contact lenses (Device)
Sequence 4
No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Narafilcon A contact lenses (Device)
Sequence 4
No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
干预措施: Somofilcon A contact lenses (Device)
结局指标
主要结局
Tear Film Evaporation Rate
时间窗: Day 1, Hour 8, each product
Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
次要结局
未报告次要终点