A clinical safety and efficacy study of Kajal for Long-Lasting, Waterproof, and Smudge-Proof Results in Healthy Adult Human Female Subjects

Maxima Solutions1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2025年3月6日最近更新: 2025年2月20日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 32
试验地点: 1
主要终点: To evaluate the effectiveness of the test product in terms of

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结


This is open-label, single-arm, single centre clinical safety and efficacy study of Kajal for Long-Lasting, Waterproof, and Smudge-Proof Results in healthy human female subjects. A sufficient number (maximum of 32) of adult female subjects will be recruited to ensure a total of 30 subjects complete the study.

Visit 01 (Day 00): Screening, ICD Obtained,

Visit 02 (Day 01): Enrolment, Visual Assessment, Digital Photographs, ophthalmological evaluation (eye irritation, redness, itchiness, and lachrymation)

Visit 03 (Day 02): 24 hours visual assessment by trained staff, digital photographs, subject perception questionnaire

Visit 04 (Day 02): 36 hours visual assessment by trained staff, digital photographs, subject’s perception questionnaire, end of study

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 70.00 Year(s)（—）
性别: Female

入选标准

•Age: 18 years and above old at the time of consent.
•Frequent | Daily user of Kajal.
•Females of childbearing potential must have a self-reported negative urine pregnancy test on Day 01 before application.
•Females who are using contact Lenses (2 to 5 female participants).
•Subjects are generally in good general health as determined from recent medical history.
•The subject does not have any previous history of adverse skin conditions and is not under any medication likely to interfere with the results.
•The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
•The subject must be able to understand and provide written informed consent to participate in the study.

排除标准

•Subjects who are visually impaired or having underlying conditions that potentially impairs their vision.
•Subject with eye makeup.
•Subjects with known history of allergies or specific allergic reactions upon using ophthalmic cosmetic products.
•Subjects with presenting ophthalmic conditions like dry eye, cataract, conjunctivitis etc.
•Subjects who have dark circles under their eyes.
•Subjects who are reported pregnant/planning a pregnancy or lactating.
•Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrolment.
•Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.