A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Slit Lamp Findings
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of the Bausch & Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).
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
- None
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
- •Subjects must have clear central corneas and be free of any anterior segment disorders.
- •Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- •Subjects must be of Asian descent.
- •Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.
排除标准
- •Subjects who have any systemic disease affecting ocular health.
- •Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Subjects with an active ocular disease or are using any ocular medication.
- •Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
- •Subjects who currently wear monovision, multifocal, or toric contact lenses.
- •Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.
结局指标
主要结局
Slit Lamp Findings
时间窗: Summarized over all follow-up visits through 1 month
Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) \> grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe
logMAR Visual Acuity (VA)
时间窗: 2 week and 1 month follow-up
Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
次要结局
- Lens Movement(Summarized over all follow-up visits through one month)
- Lens Wettability(Summarized over all follow-up visits through 1 month)
- Lens Centration(Summarized over all follow-up visits through 1 month)
- Lens Deposits(Summarized over all follow-up visits through one month)
- Symptoms & Complaints(Summarized over all follow-up visits through one month)