Clinical Evaluation of Opti-Free III Compared to Opti-Free Plus®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
研究概览
简要总结
The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Soft contact lenses habitual wearer, both eyes.
- •Voluntarily sign Informed Consent.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.
- •Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.
- •Eye infection, blepharitis, iris inflammation, or severe eye inflammation.
- •Corneal staining greater than Grade 1 at baseline.
- •Pregnant, lactating, or intend to become pregnant during study period.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein
时间窗: Day 1, after 2 hours of wear
The contact lens was removed, the cornea was stained with fluorescein (ophthalmic dye), and pictures of the corneal surface were taken. Corneal staining density was evaluated for each eye individually against representative pictures and scored on a 0-3 scale (0=No staining; 1=Staining with low density; 2=Staining with moderate density; 3=Staining with severe density). Proportion of participants is reported as a percentage.
次要结局
- Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein(Day 1, after 2 hours of wear)