Performance Evaluation of DAILIES® TOTAL1™ in First Time Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 主要终点
- Initial Comfort
研究概览
简要总结
The purpose of this study was to evaluate the performance of DAILIES® TOTAL1™ in first time contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign Informed Consent.
- •No previous contact lens experience or attempt to try contact lenses (neophyte).
- •Willing to wear study lenses for at least 8 hours a day for at least 5 days a week.
- •Use spectacle lenses for vision correction.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •45 years or older.
- •Prior wear experience with rigid or soft contact lenses.
- •Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
- •History of ocular surgery/trauma within the last six months.
- •Pregnant or nursing women.
- •Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Delefilcon A
Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
干预措施: Delefilcon A contact lens (Device)
结局指标
主要结局
Initial Comfort
时间窗: Day 1
Initial comfort was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Comfort at Insertion by Visit
时间窗: Day 7, Day 14
Comfort at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Comfort During the Day by Visit
时间窗: Day 7, Day 14
Comfort during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Comfort at End of Day by Visit
时间窗: Day 7, Day 14
Comfort at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Comfort at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Overall Comfort by Visit
时间窗: Day 7, Day 14
Overall comfort was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall comfort was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Initial Quality of Vision
时间窗: Day 1
Initial quality of vision was rated by the participant and recorded on a questionnaire at time of lens dispense. Initial quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Quality of Vision at Insertion by Visit
时间窗: Day 7, Day 14
Quality of vision at insertion was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at insertion was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Quality of Vision During the Day by Visit
时间窗: Day 7, Day 14
Quality of vision during the day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision during the day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Quality of Vision at End of Day by Visit
时间窗: Day 7, Day 14
Quality of vision at end of day was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Quality of vision at end of day was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Overall Quality of Vision by Visit
时间窗: Day 7, Day 14
Overall quality of vision was rated by the participant and recorded on a questionnaire as a single, retrospective evaluation of the previous week of lens wear. Overall quality of vision was rated on a 10-point scale (1=poor to 10=excellent) as a single assessment for both eyes.
Average Comfortable Daily Wear Time by Visit
时间窗: Day 7, Day 14
Average comfortable daily wear time was reported by the participant as a single, retrospective evaluation of the previous week of wear.
Likert Statement: These Contact Lenses Were so Comfortable That I Don't Feel Anything.
时间窗: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: These Contact Lenses Were so Comfortable That I Barely Felt Anything.
时间窗: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: These Contact Lenses Felt so Comfortable That I Forgot I Was Wearing Them.
时间窗: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: These Contact Lenses Are Perfect for When I Choose Not to Wear my Eye Glasses.
时间窗: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: I Liked These Contact Lenses so Much That I Will Recommend Them to my Friends.
时间窗: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 22=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: Overall, my Vision is Better With These Contact Lenses Compared to my Eye Glasses.
时间窗: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: At the End of the Day my Vision is Better With These Contacts Lenses Compared to my Eye Glasses.
时间窗: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=strongly agree; 1=agree; -1=disagree; -2=strongly disagree. A single assessment was made for both eyes.
Likert Statement: My Peripheral Vision is Better With These Contact Lenses Than With my Eye Glasses.
时间窗: Day 14
The participant indicated agreement/disagreement with the statement by using a 4-point scale: 2=Strongly Agree; 1=Agree; -1=Disagree; -2=Strongly Disagree. A single assessment was made for both eyes.
Likert Statement: Compared to my Eye Glasses, my Vision With These Contact Lenses is:
时间窗: Day 14
The participant indicated overall satisfaction/dissatisfaction with the contact lenses using a 5-point scale: 2=Much Better; 1=A Little Better; 0=Same; -1=A Little Worse; -2=Much Worse. A single assessment was made for both eyes.
Likert Statement: I am Interested in Purchasing These Contact Lenses.
时间窗: Day 14
The participant indicated purchase intent using a 4-point scale: 2=Very Interested; 1=Interested; -1=Not Interested; -2=Very Disinterested. A single assessment was made for both eyes.
次要结局
- Lens Surface Characteristics: Dry Areas/Non-wetting(Day 1)
- Lens Surface Characteristics: Dry Areas/Non-Wetting(Day 14)
- Duration of Overall Training Time(Day 1)
- Investigator's Satisfaction With Lens Fit by Visit(Day 1, Day 7, Day 14)
- Investigator's Overall Impression of Surface Wettability by Visit(Day 1, Day 7, Day 14)
- Investigator's Rating of Ease of Fit(Day 14)
- Lens Surface Characteristics: Dry Areas/Non-Wetting(Day 7)