NCT03684928已完成不适用
A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Ease of Insertion(Handling)
研究概览
简要总结
The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.
详细描述
This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •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, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
- •Is willing to wear contact lens in both eyes for the duration of the study;
- •Has a minimum astigmatism of - 0.75, determined by refraction;
- •Can be fit with the two study contact lens types in the powers available;
- •Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
- •Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
- •Has clear corneas and no active* ocular disease;
排除标准
- •A person will be excluded from the study if he/she:
- •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 measure;
- •Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
- •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;
- •Has participated in the previous QUENA study.
结局指标
主要结局
Ease of Insertion(Handling)
时间窗: 1 month
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
Ease of Insertion (Handling)
时间窗: 2 weeks
Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)
次要结局
- Rotational Recovery After Lens Mislocation(1 month)
研究者
研究点 (2)
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