NCT06317038已完成不适用
Performance of TOTAL30 (Lehfilcon A) Contact Lenses in Patients Using Digital Devices and 89814415
Tauber Eye Center2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear).
研究概览
简要总结
To evaluate the performance of Total 30® (lehfilcon A) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adult patients aged 18-40 of any sex and any race.
- •Reports habitually using digital device usage (phone, Ipad, computer, social media, video streaming) for 8 hours or more per day 5 days per week with plans to continue the habit throughout the study.
- •Wearing contact lenses for at least 13 hours daily 5 days per week.
- •Spherical refractive error between -11.00 D and +6.00D with < -0.75 D of astigmatism.
- •Willing to comply with the protocol instructions.
- •Has read (or has had read to), understood, and signed an Informed Consent.
- •Willing to not use any artificial tears, rewetting drops or dry eye treatments during the study.
排除标准
- •Active ocular infection or ocular inflammatory disease.
- •Presbyopic or pre-presbyopic that have a measured add power for reading.
- •Current Total 30 contact lens wearer.
- •Anterior basement membrane dystrophy or history of recurrent erosion syndrome or topographical abnormalities that might indicate ectasia or other corneal degenerative conditions.
- •Current or previous diagnosis of dry eye disease; currently using a dry eye treatment including but not limited to artificial tears, rewetting drops or prescription treatments.
- •History of severe / serious ocular pathology or other medical conditions that could result in an inability to safely complete the study.
- •Participation by the patient in any other investigational study within the past 30 days.
- •Unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.). The Principal Investigator or the Medical Monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.
- •Inability to utilize Clear Care Cleaning solution.
- •Pregnancy
结局指标
主要结局
Likert question about comfort satisfaction while wearing Total 30 contact lenses on a typical day (> 13 hours of daily wear) after 1 month of wear and heavy digital device usage (>8 hours daily wear).
时间窗: 1 month
Likert Questionaire: Strongly Disagree, Disagree, Neither Agree nor Disagree, Agree, Strongly Agree
次要结局
- Results of subjective ratings of patients using Total 30 lenses and heavy digital device usage with VAS diary questionnaire.(1 month)
- Report on total daily wear time and digital device usage.(1 month)
- Likert responses to insertion comfort and overall vision, and heavy digital device use on a typical day after 1 month of wear.(1 month)
研究者
Joseph Tauber
Crystal Remington OD, FAAO
Tauber Eye Center
研究点 (2)
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