Evaluation of the Irritation Potential of Products in Human Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Subjective assessment of discomfort in the eyes assessed by 5 point scale.
研究概览
简要总结
To evaluate the human eye irritation potential of one 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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Must be healthy males or females between the ages of 18 to 60 years inclusive with no medical conditions of the eyes.
- •Do not wear contact lenses or, if he/she does wear contact lenses, is willing to refrain from wearing these during the test period.
- •Willing to report any medications taken during the study.
- •Willing to have the test materials instilled into the eyes and follow all protocol requirements.
- •Have been informed and have given written consent to participate in the study.
排除标准
- •Has ocular disease or peri-orbital dermatitis or trauma, infections or chronic eye conditions that may affect the study outcome.
- •Has systemic illness which affects the eyes, including diabetes, thyroid disease, sarcoidosis, hypertension, atherosclerosis, lupus, multiple sclerosis, sickle cell disease, AIDs (Acquired Immune Deficiency Syndrome), severer rheumatoid arthritis. results as determined by the investigator.
- •Must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
- •Must not have received and used an Investigational New Drug within the thirty days immediately preceding the study.
研究组 & 干预措施
Sunscreen lotion Sun Protection Factor 50 (BAY987521)
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
干预措施: Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521) (Other)
Ophthalmic Ointment
Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
干预措施: Ophthalmic Ointment (Other)
结局指标
主要结局
Subjective assessment of discomfort in the eyes assessed by 5 point scale.
时间窗: Up to 1 day
Intensity of Lacrimation assessed by 5 grading scale.
时间窗: Up to 1 day
Intensity of Bulbar Conjunctiva Irritation assessed by 4 grading scale.
时间窗: Up to 1 day
Intensity of Palpebral Conjunctiva Irritation assessed by 4 grading scale.
时间窗: Up to 1 day
次要结局
未报告次要终点