How Does PRECISION7® for Astigmatism Perform in Current and Successful Acuvue® Oasys for Astigmatism Wearers?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Likert questionnaire
研究概览
简要总结
Determine the likelihood of successfully refitting a satisfied AOA CL wearers into P7A CLs
详细描述
PRECISION7m for Astigmatism is a 1-week, silicone hydrogel (serafilcon A), daily wear, contact lens (CL) with extended wear approval made of a novel material that incorporates the Activ-Flo System. The Activ-Flo System has a moisturizing agent within the CL matrix, which allows for continual release of the moisturizing agents while also providing up to 16 hours of comfortable wear and precise vision for the life of the CL. While initial P7A data are promising, the literature currently lacks a targeted study aimed at determining how patients perform in P7A after transitioning out of other commonly prescribed silicone hydrogel CLs. This transition could be particularly important for patients who have astigmatism given that they tend to struggle with CLs more than spherical CL wearers.1 Thus, the purpose of this study is to determine the success rate of refitting current, satisfied ACUVUE OASYS for Astigmatism CL wearers into P7A. Understanding how a P7A CL wearer reacts to transitioning into P7A from AOA will provide valuable information to partitioners for patient educational purposes, and it will provide credence for refitting successful AOA patients into the newer P7A technology, which could help grow the P7A CL market by not limiting P7A refits to problem-solving events.
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, AOA CL wearers with best-corrected 20/20 visual acuity or better.
- •Participants will be required to have worn AOA 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 (AOA CLs) and to indicate that they are satisfied with AOA CLs (Yes/No).
- •Participants will be required to be able to wear P7A CLs (astigmatism ≥0.75D OD/OS).
- •Astigmatism ranging from 0.75 D to 2.50 D in each eye
- •Participants will be required to wear the study CLs for ≥13 hours with no overnight wear
- •Participants will be willing to wear the CL every day of the week, except during the washout period
- •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 P7A in the past
- •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 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
Likert questionnaire
时间窗: 1 week
1\. Likelihood of continuing to wear P7A, 2. Overall satisfaction while wearing P7A, 3. Overall vision while wearing P7A, 4. End of day comfort while wearing P7A, 5. End of day vision while wearing P7A, 6. Overall comfort while wearing P7A, 7. Ability to play sports and perform fitness actives while wearing P7A, 8. Ability to use digital devices while wearing P7A (questions attached). 9. Would recommend the study CLs to a friend.
Likert questionnaire
时间窗: 1 week
1\. Likelihood of continuing to wear P7A, 2. Overall satisfaction while wearing P7A, 3. Overall vision while wearing P7A, 4. End of day comfort while wearing P7A, 5. End of day vision while wearing P7A, 6. Overall comfort while wearing P7A, 7. Ability to play sports and perform fitness actives while wearing P7A, 8. Ability to use digital devices while wearing P7A (questions attached). 9. Would recommend the study CLs to a friend.
次要结局
未报告次要终点