CTRI/2025/10/096414尚未招募Unknown
A Single Blind Clinical Study to evaluate the Eye Stinging Potential of Fame labs Soothe Stick Varient: Soothe No Colour End And Black End on healthy human volunteers
Fame Labs1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年11月3日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1. Change in Discomfort
研究概览
简要总结
In Visit 1/Day 0
Step 1: Firstly, the subject enrolls into the study as per inclusion and exclusion criteria
Step 2: Assessment of the subject as per discussed above (refer to study design)
In Visit 2/ Day 1 To check the irritation potential of the following
1. SOOTHE STICK VARIENT: DEFINE (BLACK END) BRAND- TRUTH BE TOLD
2. SOOTHE STICK VARIENT: SOOTHE (NO COLOUR END) BRAND- TRUTH BE TOLD
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subjects medical history and confirmed by an ophthalmologist
- •Subjects not under any doctor care for ocular or peri orbital diseases
- •The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.
排除标准
- •1.Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •2.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •3.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
- •4.Have participated in any interventional clinical trial in the previous 30 days.
- •5.Have a known sensitivity to any of the constituents of the test product including sensitivities to cocoamidopropyl betaine, coumarin, Aloe barbadensis etc.
- •6.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
- •7.Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
结局指标
主要结局
1. Change in Discomfort
时间窗: Time Points 0-1 days
2. Change in Lacrimation
时间窗: Time Points 0-1 days
3. Change in Conjunctival inflammation
时间窗: Time Points 0-1 days
4. Change in Cornea and iris inflammation
时间窗: Time Points 0-1 days
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Ishika Gandhi
CCFT Laboratories
研究点 (1)
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