Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Must sign an Informed Consent document;
- •Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;
- •Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;
- •Manifest astigmatism less than or equal to 0.75 D (at screening);
- •Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Eye injury in either eye within 12 weeks prior to study enrollment;
- •Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;
- •History of herpetic keratitis;
- •History of refractive surgery or irregular cornea;
- •Pathologically dry eye that precludes contact lens wear;
- •Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;
- •Monocular (only 1 eye with functional vision);
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
DT1 UV
Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours
干预措施: Delefilcon A contact lenses with UV Absorber (Device)
DT1
Delefilcon A contact lenses worn bilaterally for 9 hours
干预措施: Delefilcon A contact lenses (Device)
结局指标
主要结局
Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
时间窗: Day 1 at Hour 9 ± 3 hours
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.
次要结局
未报告次要终点