ACUVUE® OASYS With Transitions™ Light Intelligent Technology™ Clinical Performance Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 20
- 主要终点
- Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
研究概览
简要总结
This registry study is a one-year, one-visit, observational, prospective, open-label, two-arm, multi-center, multi-national, post-market study of approximately 300 patients who have recently been fitted with the ACUVUE® OASYS with Transitions™ and approximately 300 patients who have recently been fitted with spherical nonphotochromic reusable marketed silicone hydrogel contact lenses (of any brand). Eligible subjects will be asked to complete a Patient Registration Questionnaire several times throughout the year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •Contact lens neophytes or those who have recently (i.e. within last 2 months) begun the use of a new lens type and have purchased a supply of lenses.
- •A minimum age of 18 years, with no maximum age.
- •The registrant must read and sign the Informed Consent form.
- •The registrant must appear able and willing to adhere to the instructions set forth in this clinical protocol.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- •Current participant in another research study.
- •Employee or relative of site, or family member of Recruiting Practitioner or Johnson & Johnson.
- •Non-spherical contact lens wearers, i.e. toric or multifocal lenses.
结局指标
主要结局
Vision Satisfaction in Bright Lighting - 2-Week Questionnaire
时间窗: 2-week questionnaire follow-up
Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported.
Vision Satisfaction in Bright Lighting - 4-Month Questionnaire
时间窗: 4-month questionnaire follow-up
Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary. The number of missing responses in each lens group was reported.
Vision Satisfaction in Bright Lighting - 12-Month Questionnaire
时间窗: 12-month questionnaire follow-up
Subjects will be asked to evaluate their vision satisfaction in bright lighting by rating their level of agreement with the statement "I am satisfied with the quality of my vision in bright lighting with these contact lenses" using a 5-point agreement Likert scale (Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, and Strongly Agree). In the Control group 4 subjects were identified as ineligible after the screening visit because they were wearing ineligible Control lenses. Therefore, only 54 subjects were included in the Control group for the primary endpoint data summary.
次要结局
- Overall Quality of Vision - 2-Week Questionnaire(2-week questionnaire follow-up)
- Overall Quality of Vision - 4-Month Questionnaire(4-month questionnaire follow-up)
- Overall Quality of Vision - 12-Month Questionnaire(12-month questionnaire follow-up)
- Overall Comfort - 2-Week Questionnaire(2-week questionnaire follow-up)
- Overall Comfort - 4-Month Questionnaire(4-month questionnaire follow-up)
- Overall Comfort - 12-Month Questionnaire(12-month questionnaire follow-up)
- Pulfrich Effect(2-week, 4-month, and 12-month questionnaire follow-up)
- Serious or Significant Adverse Events(Throughout the duration of the study, up to 12 months)