A Comparative Study of Two Daily Disposable Contact Lenses in Higher Myopia Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Change in Average Central Corneal Curvature From Dispense at Week 1
研究概览
简要总结
The purpose of this study is to compare the change from baseline in central corneal curvature at one week, between 2 silicone hydrogel lenses, in higher myopic subjects.
详细描述
Participants were expected to attend 4 office visits. Visit 1 was the Screening/Enrollment visit. At Visit 2 (Baseline Visit), participants were randomized and the study lenses were trial fit. At Visit 3 (Dispense Visit), participants received study lenses for approximately 1 week of wear. Visit 4 was the Exit visit. Expected duration of participation in the study was 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign Informed Consent document;
- •Higher degree of myopia in both eyes, i.e. habitual contact lens power between -10.00 diopters (D) and -17.00D;
- •Best corrected distance visual acuity greater than or equal to 20/30 in each eye (measured with either spectacle refraction or habitual contact lenses plus over refraction);
- •Manifest astigmatism less than or equal to -1.00D;
- •Soft contact lens wear in both eyes at least 5 days per week and at least 8 hours per day;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Pregnant or lactating;
- •Eye injury or surgery within twelve weeks immediately prior to enrollment;
- •Any ocular condition that contraindicates contact lens wear;
- •History of herpetic keratitis;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including any use of topical ocular medications that would require instillation during contact lens wear, except for approved lubricating drops;
- •Clinical significant dry eye not responding to treatment;
- •Previous corneal or refractive surgery or irregular cornea;
- •Requires reading glasses;
- •Participation in a clinical trial (including contact lens or contact lens care product) within the previous 30 days;
- •Wears habitual lenses in an extended wear modality (routinely sleeps in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Change in Average Central Corneal Curvature From Dispense at Week 1
时间窗: Dispense (Day 1 of lens wear), Week 1 (Day 8 of lens wear)
Corneal curvature (horizontal and vertical keratometry values on the same eye) was measured using a calibrated keratometer prior to study lens dispense (Day 1) and approximately 15 minutes after study lens removal following 8 hours of wear (Week 1). Minus values in change-from-baseline indicate corneal flattening.
次要结局
- Number of Eyes With Change of >1.00 Diopter (D) in Spherical Equivalent of Subjective Refraction From Baseline at Week 1(Baseline, Week 1 (Day 8 of lens wear))