Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dryness
研究概览
简要总结
Bilateral dispensing study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric lenses
详细描述
Prospective, double-masked (investigator and participant), bilateral, randomized, cross-over dispensing study comparing the MyDay Toric (test) against the 1-day Acuvue Moist for Astigmatism (control), and Dailies Aquacomfort Plus Toric (control) lenses
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has had a self-reported oculo-visual examination in the last two years.
- •Has read and signed an information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Is an adapted soft contact lens wearer;
- •Is willing to wear contact lens in both eyes for the duration of the study;
- •Has a minimum spectacle astigmatism of - 0.75;
- •Can be fit with the three study contact lens types in the powers available;
- •Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best corrected vision (for binocular distance acuity);
- •Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the study contact lenses.
- •Has clear corneas and no active* ocular disease;
- •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 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.
排除标准
- •Is participating in any concurrent clinical trial;
- •Has any known active* ocular disease and/or infection;
- •Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- •Has known sensitivity to fluorescein dye or products to be used in the study;
- •Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
- •Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- •Is aphakic;
- •Has undergone refractive error surgery.
研究组 & 干预措施
MyDay Toric
Participants were randomized to wear a new pair of MyDay Toric lenses each day for one week during the cross over study
干预措施: MyDay Toric (Device)
1-Day Acuvue Moist for Astigmatism
Participants were randomized to wear a new pair of 1-Day Acuvue Moist Toric lenses each day for one week during the cross over study
干预措施: 1-Day Acuvue Moist for Astigmatism (Device)
Dailies Aquacomfort Plus Toric
Participants were randomized to wear a new pair of Dailies Aquacomfort Plus Toric lenses each day for one week during the cross over study
干预措施: Dailies Aquacomfort Plus Toric (Device)
结局指标
主要结局
Dryness
时间窗: 1 week
Subjective ratings of lens performance for dryness assessed. Dryness Scale 0-10, 0=extremely dry, 10=no dryness
Visual Quality
时间窗: 1 week
Subjective ratings of lens performance for visual quality assessed. Visual quality Scale 0-10, 0=completely dissatisfied, 10=completely satisfied
Comfort
时间窗: 1 week
Subjective ratings of lens performance for comfort assessed. Comfort Scale 0-10, 0=painful, 10=can't feel the lenses.
Lens Preference With Respect to Overall Comfort
时间窗: 1 week
Overall comfort preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
Lens Preference With Respect to Visual Quality
时间窗: 1 week
Overall visual quality preference of MyDay Toric, 1-Day Acuvue Moist Toric or Dailies Aquacomfort Plus Toric lenses. Scale: Strong or Slight preference for one lens, or No-preference
次要结局
未报告次要终点