DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 192
- 试验地点
- 12
- 主要终点
- Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric
研究概览
简要总结
The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.
详细描述
This study includes a Baseline visit and a Year 1 visit.
The Baseline visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a DAILIES TOTAL1 sphere, toric, or multifocal soft contact lens prescription was released. The Baseline visit will be retrospective. All assessments at baseline will be obtained from chart reviews.
The Year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed. The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age. For subjects 18 years of age and older, the Year 1 visit will be retrospective.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At baseline: 7 years of age or older for sphere and toric wearers, 40 years of age or older for multifocal wearers.
- •Wearers of delefilcon A (sphere, toric, or multifocal) soft contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at baseline.
- •Best corrected distance visual acuity (BCVA) 20/25 or better in each eye at baseline.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular disease or condition that would contraindicate contact lens wear at baseline.
- •Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric
时间窗: Baseline
Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses.
Distance visual acuity with study lenses at Year 1 Follow-up - Sphere and Toric
时间窗: Year 1 Follow-Up
Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses.
Distance visual acuity with study lenses at Baseline - Multifocal
时间窗: Baseline
Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Distance visual acuity with study lenses at Year 1 Follow-Up - Multifocal
时间窗: Year 1 Follow-Up
Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Near visual acuity with study lenses at Baseline - Multifocal
时间窗: Baseline
Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Near visual acuity with study lenses at Year 1 Follow-Up - Multifocal
时间窗: Year 1 Follow-Up
Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Incidence of corneal infiltrative events
时间窗: Up to Year 1
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
Incidence of microbial keratitis
时间窗: Up to Year 1
Microbial keratitis is a sight-threatening infection of the cornea.
次要结局
未报告次要终点