Assessment Of The Skin And Ocular Tolerance Of The Product Systane® Lid Wipes (050343-01) And Assessment Of The Study Subject Acceptance, Under Normal Use Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Number of Participants With a Contact-dermatitis Adverse Reaction
研究概览
简要总结
The purpose of this study is to verify the skin and ocular tolerance of the product Systane® Lid Wipes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must sign informed consent.
- •Agree to adhere to the procedures and requirements of the study.
- •Wears makeup daily.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Pregnant or breastfeeding.
- •Ocular conditions as specified in protocol.
- •Medical conditions as specified in protocol.
- •Skin conditions as specified in protocol.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Number of Participants With a Contact-dermatitis Adverse Reaction
时间窗: Day 21
Participants were assessed by a dermatologist. Contact-dermatitis adverse reaction was characterized by the presence of one or more of the following symptoms or signs: strong itching sensation, erythema, edema, desquamation, papules or vesicles. Both eyes contributed to the analysis.
Number of Participants With Ocular Clinical Signs and Discomfort Sensations
时间窗: Day 21
Participants were assessed by an ophthalmologist. Ocular clinical signs included palpebral edema, conjunctival edema, orbicular secretion, keratoconus, blepharitis, meibomitis, pterygium, hyperemia, chemosis, keratitis, secretion and lacrimation. Both eyes contributed to the analysis.
次要结局
未报告次要终点