One Month Performance Comparison Between 2 Commercially Available Silicone Hydrogel Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- Comfort at End of Day
研究概览
简要总结
The purpose of this study is to compare the performance of two commercially marketed contact lenses when worn for up to one month in a daily wear modality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Habitual spherical soft contact lens wearer who wears a contact lens brand with a recommended replacement schedule of 2 weeks or greater.
- •Have a need for correction in both eyes and be correctable to at least 20/40 distance vision in each eye at the dispense of study lenses.
- •Willing and able to wear spherical contact lenses within the available range of powers.
- •Wears contact lenses at least 5 days per week and at least 10 hours per day, removing them nightly.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Eye injury or surgery within twelve weeks prior to enrollment.
- •Currently enrolled in any clinical trial.
- •Any use of medications for which contact lens wear could be contraindicated, as determined by the investigator.
- •Astigmatism of 1.00D or more.
- •Currently wearing contact lenses in a daily disposable modality.
- •Currently wearing AIR OPTIX AQUA or ACUVUE ADVANCE Plus contact lenses.
- •Currently sleeping overnight in contact lenses on an occasional or extended wear basis.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Comfort at End of Day
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Comfort on Insertion
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Comfort During the Day
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Daytime Vision
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Low Light Vision
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Handling on Insertion
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Handling at Removal
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.
Delivers a Healthy, Natural Feeling
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Lens Awareness
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.
Overall Satisfaction
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.
Purchase Intent
时间窗: 4 weeks
As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.
次要结局
未报告次要终点