An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Lens fit (position on the eye) in mm
研究概览
简要总结
This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.
详细描述
This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects will be masked to lens type and lens codes. A sealed decoding envelope will be provided to the investigator. In the event of an emergency the investigator will break the masking and the medical monitor will be notified.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-70 years.
- •Able to read, comprehend and sign an informed consent.
- •Willing to comply with the wear and study assessment schedule.
- •Spherical distance prescription between -0.50 and -6.00 (inc.).
- •Astigmatism, if present,≤1.50DC in both eyes.
- •Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •A clear central cornea. No anterior segment disorders. No clinically significant slit lamp findings (i.e. corneal oedema, significant staining, central scarring, infiltrates, active neovascularisation). No other active ocular disease (including pterygia).
排除标准
- •Previous anterior ocular surgery
- •Any active corneal infection, injury or inflammation
- •. •Large pinguecula likely to affect soft lens fit
- •Systemic or ocular disease or medication which might interfere with CL wear
- •Pregnancy or breastfeeding
- •Participation in any concurrent trial
研究组 & 干预措施
First Pair Senofilcon A contact lens
The first pair of Senofilcon A contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the first pair Senofilcon A contact lens and subsequent removal.
干预措施: First pair Senofilcon A contact lens (Device)
Second pair Senofilcon A contact lens
The second pair of contact lenses is applied (according to the fitting schedule), allowed to settle before assessment of the second pair Senofilcon A contact lens and subsequent removal.
干预措施: Second pair Senofilcon A contact lens (Device)
Third pair Senofilcon A contact lens
The third pair of Senofilcon A contact lens is applied (according to the fitting schedule), allowed to settle before assessment of the third pair Senofilcon A contact lens and subsequent removal.
干预措施: Third pair Senofilcon A contact lens (Device)
结局指标
主要结局
Lens fit (position on the eye) in mm
时间窗: 25 minutes
Horizontal Lens Centration (mm), Vertical Lens Centration (mm), Post-blink movement in primary gaze (mm), Version lag (mm), Horizontal corneal overlap (mm), Diameter acceptance (mm),
Lens edge tightness fit grade 0-4
时间窗: 5 minutes
Edge tightness (grade 0-4)
Lens tightness fit graded as %
时间窗: 5 minutes
Tightness (push-up %),
Lens overall fit grade 0-5
时间窗: 5 minutes
Overall fit acceptability (Grade 0-5),
次要结局
未报告次要终点
研究者
Graeme Young
Graeme Young PhD MPhil FCOptom DCLP
Visioncare Research Ltd.