CTRI/2022/07/043782尚未招募不适用
To evaluate Ophthalmological safety of test product involving subjects of normal eye conditions on healthy female subjects.
ONESTO LABS PVT LTD1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2022年6月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Opthalmological Safety
研究概览
简要总结
Objective: To evaluate Ophthalmologicalsafety of test product involving subjects of normal eye conditions on healthyfemale subjects.
Duration of study: 4 days study
Kinetics: T0 (before productapplication), T+30 minutes after product application, T+1 day, T+3 days
Population: 33 healthy female subjects
Techniques Involved are;
1. Subject SelfEvaluation: for product safety,
2. Opthalmologicalevaluation :The test area is checked for irritation caused due to the products.The parameters to be evaluated are; 1.Redness 2. Watery eyes 3. Dryness 4. Itching 5. Irritation 6. Burning of eyes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Indian Female subjects 2.Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup) 3.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….) 4.Having normal eye conditions 5.Having habit of using under eye cream.
排除标准
- •6.Being pregnant or breastfeeding or having stopped to breastfeed in the past three months 7.Having refused to give his/her assent by not signing the consent form 8.Taking part in another study liable to interfere with this study 9.Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 10.Having a progressive asthma (either under treatment or last fit in the last 2 years) 11.Being epileptic.
- •12.Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 13.Having cutaneous hypersensitivity 14.Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products.
- •15.Following a chronic medicinal treatment comprising any of the following products: aspirin based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol) 16.Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months.
- •17.Having changed her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit 18.Having applied a cosmetic product (included make-up) or skin care product on the studied areas the first day of the study (only face cleaned with water is accepted) 19.Refusing to follow the restrictions below during the study: Do not take part in any family planning activities leading to pregnancy and breastfeeding Do not take part in another study liable to interfere with this study Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Mascot Spincontrol 10 / 21 Product A XXX-6Y01-DD-JE22-XXX-PR (V01) Reference of the specification SPE-CNL-PM02-Main Part of Protocol-02-I This document is the property of Mascot Spincontrol.
- •D:QASTUDY DOCUMENTSXXX-6Y01-DD-JE22XXX-6Y01-DD-JE22-XXX- PR (V01) 2022 06 18.docx Do not change cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit.
- •During the study: Do not use other eye related and/ or eye make up than the tested products to the studied areas.
- •The day of the measurements: No test product or any other eye make up must be used 20.Having applied make-up products on eyes in the 48 hours preceding the start of the study.
- •21.Having permanent make-up on the studied area.
- •22.Having ocular problems (stye, chalazion, conjunctivitis).
- •23.Having applied an eye product and/or make up for eye, to the studied area the day of the measurements.
- •24.Do not itch the eyes 25.Do not use any eye drops or any eye treatment/ surgery during the study.
结局指标
主要结局
Opthalmological Safety
时间窗: T0, 30 minutes, day 1, Day 3
次要结局
未报告次要终点
研究者
研究点 (1)
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