How Does Total 30 Sphere Perform in Those Who Previously Dropped Out of Contact Lenses Due to Comfort or Dryness?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Likelihood of continuing to wear T30 CLs at 1 month and 6 months
研究概览
简要总结
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear."
详细描述
Contact lens (CL) discomfort is a complex phenomenon that has been defined by the Tear Film and Ocular Surface Society (TFOS) in their seminal report on CL discomfort as a condition that results in "episodic or persistent adverse ocular sensation related to lens wear, either with or without visual disturbance resulting from reduced compatibility between the CL and the environment, which can lead to decreased wearing time and discontinuation of CL wear."1 While CL dropout occurs in about 20% of wearers annually the majority of CL wearers who cease wearing their CLs have a desire to continue wearing their CL if given the opportunity.3 A recent review by Pucker and Tichenor found that CL discomfort was the top reason for established CL wears to cease wearing CLs Therefore, providing CL dropouts with an alternative material, which may be more comfortable than their past CLs, could be a means for curbing CL dropout.
Our recent work found that when 60 participants who had previously dropped out of CLs were given the opportunity to be refit into Dailies TOTAL1® CLs that 100% of them were still wearing Dailies TOTAL1® at 1 month and 98% of them were still wearing their CLs at 6 months. When these participants were asked at the 1-month visit, 98.3%, 86.5%, and 93.2% of them responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort, and overall CL comfort, respectively. These same participants responded at 6 months that they were very likely or likely to continue to wear the study CLs (80.7%) and to recommend the study CLs to a friend (93.2%). While these data suggest that CL dropout can thrive when being refit into a daily disposable CLs, the literature currently lacks a targeted study aimed at understanding how CL dropouts will respond to being refit into a monthly replacement CL. One good potential monthly CL option is the TOTAL30® (T30) CL. T30 is a relatively new frequent replacement CL, with a biocompatible design. Thus, the purpose of this study is to determine the frequency that CL dropouts who dropped out of CLs because of dryness or discomfort can be comfortably refit into T30 CLs at 1 month.
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
- •Adults, 18- to 40-year-old, past CL wearers who have best corrected 20/20 visual acuity or better
- •Participants will be required to have worn reusable CLs for at least one year in the past.
- •Participants over the age of 40 years will be excluded to avoid presbyopia-related vision issues.
- •Participants must have dropped out of reusable CLs within the past two years because of discomfort or dryness.
- •This determination will be made by listing Young et al.'s list of reasons for dropping out of CLs and asking the participants to indicate their top reason for dropping out of CLs:
- •a. Discomfort or Dryness b. General Poor Vision, c. Poor Reading Vision, d. Difficulty with Handling, e. Advised by Practitioner, f. Inconvenient, g. Eyes were Red, h. Lost Interest, i. Too Costly, j. Reaction to Care Products, k. Lost Lenses, l. Other.
- •. Participants will be considered a CL dropout if they have not worn CLs in the past 3 months. Participants will be required to have scores of ≤3 on the SPEED questionaries' (no significant dry eye symptoms).
- •Participants will be required to be able to wear T30 sphere CLs (astigmatism ≤ 0.75 D OD/OS).
- •Participants will be required to provide a prescription for glasses that is less than 3 years old.
排除标准
- •if they are past rigid CL wearers,
- •have worn reusable CLs within the past two years,
- •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, or
- •if they are pregnant or breast feeding.
研究组 & 干预措施
T30 For Dropouts
Total 30 contact lenses for those who have previously dropped out of CL wear
干预措施: T30 Contact lenses (Device)
结局指标
主要结局
Likelihood of continuing to wear T30 CLs at 1 month and 6 months
时间窗: 1 month and 6 months
Participants will be refit into new contact lenses and their comfort will be asked about their comfort.In which a higher score is better.
Overall satisfaction while wearing T30 CLs at 1 month and 6 months.
时间窗: 1-6 months
Comfort in the lenses will be judged at 1 and 6 months to determine if the participant is satisfied using Visual Acuity scores in which higher scores are better.
Likelihood of continuing to wear T30 CLs at 1 month and 6 months
时间窗: 1 month and 6 months
Participants will be refit into new contact lenses and their comfort will be asked about their comfort.In which a higher score is better.
Overall satisfaction while wearing T30 CLs at 1 month and 6 months.
时间窗: 1-6 months
Comfort in the lenses will be judged at 1 and 6 months to determine if the participant is satisfied using Visual Acuity scores in which higher scores are better.
次要结局
未报告次要终点