A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Dryness
研究概览
简要总结
The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.
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
- 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, 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
- •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 PIANO (i.e. EX-MKTG-83) Study.
结局指标
主要结局
Dryness
时间窗: 1-month
Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)
Comfort at Insertion
时间窗: Dispense
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Comfort
时间窗: 1-month
Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)
Lens Preference Based on Overall Comfort
时间窗: 1 month
Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
Lens Preference Based on Overall Dryness
时间窗: 1 month
Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)
次要结局
- Ease of Removal(1 month)
- Ease of Insertion(1-month)