NCT06308666已完成不适用
Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use
研究概览
简要总结
The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day).
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
- •Are between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
- •Have read and signed an information consent letter;
- •Are willing and able to follow instructions and maintain the appointment schedule;
- •Are a digital device user (at least 8 hours on a typical day using any combination of digital devices such as personal computer [PC], laptop, smartphone or tablet);
- •Are a habitual wearer of daily wear, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 13+ hours/day on a typical day during the month prior to enrolment;
- •The habitual lens type brand will be restricted such that a maximum of 7 participants will be included in the study for each lens brand/material;
- •Have a vertex corrected spherical equivalent distance refraction within -0.50 Diopter (D) to -9.00D in each eye;
- •Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in each eye after vertexing to the corneal plane;
- •Demonstrate an acceptable fit and achieves best corrected visual acuity of at least 0.10 logMAR in each eye with DAILIES TOTAL1® contact lenses;
- •Are willing to wear DAILIES TOTAL1® contact lenses at least 5 days per week and 13+ hours per day throughout the study.
排除标准
- •Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
- •Are presbyopic or habitually use a reading addition for close work;
- •Have any known active* ocular disease and/or infection; [* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.]
- •Meet the diagnosis of dry eye disease as per the following combination:
- •Meets the symptom criteria of Contact Lens Dry Eye Questionnaire (CLDEQ-8) score ≥12
- •And they show 1 of the following 2 signs:
- •Either sodium fluorescein (NaFl) staining (either [cornea >5 dots] or [conjunctiva >9 dots] or [lid margin >2mm length AND ≥25% width]);
- •Or non-invasive tear film break-up time (NITBUT) (no contact lens) <10 seconds.
- •Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;+ [+ Any potential exclusion will be reviewed with the Lead Investigator or Principal Investigator prior to final decision making.]
- •Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Are a current wearer of DAILIES TOTAL1® daily disposable contact lenses;
- •Have known sensitivity to the diagnostic pharmaceutical sodium fluorescein to be used in the study;
- •Have undergone refractive error surgery;
- •Are a member of the Centre for Ocular Research & Education (CORE) directly involved in the study.
结局指标
主要结局
Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use
时间窗: Day 14+2
Participants rate their overall clarity of vision after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Rating of Comfort After 8 Hours or More of Digital Device Use
时间窗: Day 14+2
Participants rate their overall comfort after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Rating of Dryness After 8 Hours or More of Digital Device Use
时间窗: Day 14+2
Participants rate their overall dryness after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
次要结局
未报告次要终点
研究者
研究点 (2)
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