Evaluation of the Stinging Potential 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
- 40
- 主要终点
- Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale.
研究概览
简要总结
The objective of this study was to compare the human eye stinging potential of experimental formulas and an industry standard shampoo mixture. The study was conducted under the supervision of a Board Certified Ophthalmologist.
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
- Single (Participant)
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
- •Male or female subjects, aged 18 to 60 years
- •No medical conditions of the eyes as determined by the subjects' medical history and confirmed by ophthalmologist
- •Subjects do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the day of and day after the study
- •Subject is willing to have the test materials instilled into the eyes and follow all protocol requirements
- •Subject is willing to refrain from using false eyelashes of any type or any topical prescription, OTC or cosmetic products on their eyes, eyelids, eyelashes or the peri-orbital areas of the face on the day of the study.
- •Subjects should refrain from use of make-up on testing day
排除标准
- 未提供
研究组 & 干预措施
Suncare agent 2 + control
Application of control and test product into one of the subjects two eyes.
干预措施: BAY 987516 (Y65-118) (Drug)
Suncare agent 1 + control
Application of control and test product into one of the subjects two eyes.
干预措施: BAY 987516 (Y65-122) (Drug)
Suncare agent 1 + control
Application of control and test product into one of the subjects two eyes.
干预措施: Control (Drug)
Suncare agent 2 + control
Application of control and test product into one of the subjects two eyes.
干预措施: Control (Drug)
结局指标
主要结局
Subjective discomfort in the eye was assessed based on questions by an Ophthalmologist to the subject, and a 5-category intensity scale.
时间窗: up to 24 hours
Tearing/Lacrimation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
时间窗: up to 24 hours
Objective inflammation was assessed by the Ophthalmologist using a 5-category assessment score for each of the categories
时间窗: at 24 hours
Post installation pain/stinging was assessed using a 5-category intensity score
时间窗: at 24 hours
Post installation itching was assessed using a 5-category intensity score
时间窗: at 24 hours
Post installation dryness was assessed using a 5-category intensity score
时间窗: at 24 hours
Post installation scratchiness was assessed using a 5-category intensity score
时间窗: at 24 hours
Post installation discomfort preventing sleep was assessed using a 5-category intensity score
时间窗: at 24 hours
Post installation discomfort upon awakening was assessed using a 5-category intensity score
时间窗: at 24 hours
Post installation excessive discharge upon awakening was assessed using a 5-category intensity score
时间窗: at 24 hours
Post installation pain in bright sunlight was assessed using a 5-category intensity score
时间窗: at 24 hours
次要结局
- Number of adverse events as a measure of safety and tolerabilitay(at 24 hours)