A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The objective of the study is to evaluate the product performance of visual acuity of the Bausch + Lomb investigational daily disposable contact lenses compared to the currently marketed Johnson & Johnson Acuvue Moist contact lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 be adapted soft contact lens wearers that are interested in daily disposable wear or currently adapted daily disposable soft contact lens wearers.
- •Subjects must agree to wear study lenses on a daily disposable basis for approximately one week and crossover to wear another study lens for one week.
- •Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- •Subjects must have clear central corneas that are free of any anterior segment disorders.
- •Subjects must be myopic and require lens correction from -1.00 D to -6.00 diopters (D) in each eye.
排除标准
- •Subjects who have worn gas permeable contact lenses within the last 30 days or who have worn polymethylmethacrylate lenses within the last 3 months.
- •Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an affect on ocular health during the course of the study.
- •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 who are using any ocular medication.
- •Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
- •Subjects who currently wear monovision, multifocal, or toric contact lenses.
- •Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
- •Subjects with anisometropia (spherical equivalent) of greater than 1.00 D.
- •Subjects with any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation).
- •Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- •Subjects with any "Present" finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation) 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 are aphakic.
- •Subjects who are amblyopic.
- •Subjects who have presbyopia.
- •Subjects who have had any corneal surgery (eg, refractive surgery).
- •Subjects who are allergic to any component in the study care products.
结局指标
主要结局
Visual Acuity
时间窗: Dispensing Visit and 1 week follow-up
Distance High contrast logMAR visual acuity (VA), difference between the test and control lens at dispensing visit and 1 week follow-up, crossover visit and 1 week follow-up.
Slit Lamp Examination > Grade 2
时间窗: All study visits from screening through 2 week follow-up
Slit lamp findings for each eye will be assessed at each study visit, including epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Slit lamp \> 2.
次要结局
未报告次要终点