A Single Blind Clinical Study to Evaluation Of Eye Stinging Potential of Brainbees Babyhug Daily Face & body Milky Foam Wash
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in lacrimation
研究概览
简要总结
single arm clinical study.
5 μL of the appropriate test should be instilled into the lower conjunctival sac of one eye, and another eye should be instilled with Normal Saline as Negative control. No Positive control to be taken.
Assessment would be done as 5-point scale for the below attributes after 1 min/2 min/5 min.
Subjective discomfort,
Score 0: No discomfort felt Score 1: Faint, barely perceptible discomfort Score 2: Mild, low intensity discomfort that does not prevent the subject from opening lids Score 3: Moderately intense discomfort that interferes with but does not prevent lid opening Score 4: Severe, very intense discomfort that makes voluntary lid opening difficult, requires force to pull lids apart, and results in the subject requesting washout of test article
Objective lacrimation,
Score 0: No tearing or lid wetness above normal Score 1: Noticeable increase in moistness of lid edges - no frank tearing Score 2: Frank tearing - meager flow Score 3: Frank tearing - moderate flow Score 4: Frank tearing - copious flow
- Objective conjunctival inflammation,
Score 0: Inflammatory changes absent Score 1: Capillaries slightly more prominent than they were at time of baseline examination Score 2: Capillaries very prominent plus some diffuse conjunctival reddening Score 3: Vessels very prominent plus diffuse and confluent intense redness Score 4: Beefy redness and everted lids
- Objective cornea and iris inflammation
Score 0: No effect detected with use of slit lamp Score 1: Barely perceptible clouding or pitting of cornea or thickening of iris detected via slit lamp Score 2: Faint clouding or pitting of cornea and/or thickening of the iris Score 3: Moderate clouding or pitting of cornea and/or thickening of the iris Score 4: Intense clouding orpitting of cornea and/or thickening of the iris
A follow-up visit is done after 24 hours to assess any adverse effect after the Product application
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
Change in lacrimation
时间窗: 0min, 1min, 5min
次要结局
- Change in conjunctival inflammation(0min, 1min, 5min)
- Change in cornea and iris inflammation(0min, 1min, 5min)
- Change in Subject Discomfort(0min, 1min, 5min)
研究者
Dr Ishika Gandhi
CCFT Laboratories