Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Incidence of Ocular Discomfort Device-related Adverse Events (AE)
研究概览
简要总结
The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 wearer of commercial DAILIES TOTAL1® contact lenses;
- •Have spectacles in current prescription available to be worn in conjunction with the investigational product;
- •Manifest astigmatism less than or equal to 0.75 diopter (D) (at screening)
- •Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;
- •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;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- •History of herpetic keratitis, refractive surgery or irregular cornea;
- •A pathologically dry eye that precludes contact lens wear;
- •Concurrent participation in a contact lens or contact lens care product clinical trial within the previous 30 days;
- •Monocular (only 1 eye with functional vision);
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
DT1 MF MM
Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours
干预措施: Delefilcon A Multifocal Contact Lenses with Molded Mark (Device)
DT1 MF
Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
干预措施: Delefilcon A Multifocal Contact Lenses (Device)
结局指标
主要结局
Incidence of Ocular Discomfort Device-related Adverse Events (AE)
时间窗: Day 1 at Hour 9
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.
次要结局
- Ocular Staining(Day 1 at Hour 9)
- Limbal Hyperemia(Day 1 at Hour 9)