Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
研究概览
简要总结
The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 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
- 是
入选标准
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Use a lens care system on a regular basis.
- •Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
- •Willing to use drops 4 times per day.
排除标准
- •Participating in a conflicting study.
- •An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
- •Any scar or neovascularization within the central 4mm of the cornea.
- •Any grade 2 or greater finding during the slit lamp examination
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •Amblyopic.
- •Allergic to any component in the study care products.
- •Have had any corneal surgery.
研究组 & 干预措施
Lubricating and Rewetting Drops
Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.
干预措施: Lubricating and Rewetting Drops (Device)
AMO Blink Contacts Lubricant Eye Drops
AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week
干预措施: AMO Blink Contacts Lubricant Eye Drops (Device)
结局指标
主要结局
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
时间窗: At 1 week follow up
Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \> grade 2, across abnormalities.
次要结局
未报告次要终点