How Does DT1 Sphere Perform in Current and Successful Acuvue MAX Wearers?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Likelihood of continuing to wear DT1
研究概览
简要总结
The goal of this prospective study is to to understand if satisfied MAX Contact lens (CL)wearers can be successfully refit into Dailies total 1 (DT1) CL in healthy MAX CL wearers between the ages of 18-40. The main question is to determine the number of participants who can successfully be re-fit into DT1 CL, by utilizing a cldeq-8 questionnaire as well as an investigator developed questionnaire to gauge comfort and satisfaction.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Adults, 18- to 40-year-old, Oasys MAX 1-day CL wearers with best-corrected 20/20 visual acuity or better.
- •Participants will be required to have worn Oasys MAX 1-day CLs for at least 3 months in the past year and currently wearing these CLs.
- •All participants will be required to have a CLDEQ-8 score <12 while wearing their habitual CLs (Oasys MAX 1-days) and to indicate that they are satisfied with Oasys MAX 1-day CLs (Yes/No).
- •Participants will be required to be able to wear DT1 Sphere CLs (astigmatism < 0.75D OD/OS).
- •Participants will be required to wear the study CLs for ≥12 hours with no overnight wear
- •Participants will be required to use digital devices at least 8 hours/day.
- •Participants will be required to provide a glasses prescription that is less than 3 years old.
排除标准
- •Have presbyopia and/or need a reading add as determined during their initial manifest refraction.
- •Have worn DT1 in the past for more than 1 week.
- •Are past rigid CL wearers.
- •Have a history of being diagnosed with dry eye or ocular allergies.
- •Have known systemic health conditions that are thought to alter tear film physiology.
- •Have corrected acuity 1 line or more worse vision recorded at Visit 2 (compared to the Visit 1 findings) with their optimized Oasys MAX 1-day lenses.
- •Have a history of viral eye disease.
- •Have a history of ocular surgery.
- •Have a history of severe ocular trauma.
- •Have a history of corneal dystrophies or degenerations.
- •Have active ocular infection or inflammation.
- •Are currently using isotretinoin-derivatives or ocular medications.
- •Are pregnant or breast feeding
结局指标
主要结局
Likelihood of continuing to wear DT1
时间窗: 3 weeks
A Likert questionnaire will be used to determine patient-reported outcomes -50 being uncomfortable and 50 being extremely comfortbale
Overall satisfaction while wearing DT1
时间窗: 3 weeks
A Likert questionnaire will be used to determine patient-reported outcomes. With answers that are positive such as strongly agree to product satisfaction are better.
次要结局
未报告次要终点