Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 23
- 主要终点
- Macroscopic evaluations for Lacrimation (score 0-4)
研究概览
简要总结
Evaluation of the human eye irritation potential of a test sunscreen formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be healthy males or females between the ages of 18 to 60 years inclusive.
- •Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study.
- •Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study.
- •Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.
排除标准
- •Subjects have ocular disease or peri-orbital dermatitis or trauma.
- •Subjects have a systemic illness which contra-indicates participation.
- •Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
- •Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.
研究组 & 干预措施
Sunscreen / Arm 1
Subjects will be escorted to a separate room for instillation of the test materials. Test materials will be instilled in immediate succession and with a randomized order of presentation. A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the eyes of the subject forming sacs in the conjuntival tissue, apply one test product to one eye.
干预措施: BAY987521 (Drug)
Control
A trained technician will use the thumb and forefinger of one hand to retract the lower eyelid from the other eyes of the subject forming sacs in the conjuntival tissue, apply control materials to this eye, follow the same procedure, using a new pipet tip or steriled dropper.
干预措施: Control (Drug)
结局指标
主要结局
Macroscopic evaluations for Lacrimation (score 0-4)
时间窗: up to 1 hour post instillation
Subjective assessment of discomfort (score 0-4)
时间窗: up to 1 hour post instillation
Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)
时间窗: up to 1 hour post instillation
Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)
时间窗: up to 1 hour post instillation
次要结局
未报告次要终点