CTRI/2025/10/096414
Not yet recruiting
Post Marketing Surveillance
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 site in 1 country32 target enrollmentStarted: November 3, 2025Last updated:
Overview
- Phase
- Post Marketing Surveillance
- Status
- Not yet recruiting
- Sponsor
- Fame Labs
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- 1. Change in Discomfort
Overview
Brief Summary
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
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1. Change in Discomfort
Time Frame: Time Points 0-1 days
2. Change in Lacrimation
Time Frame: Time Points 0-1 days
3. Change in Conjunctival inflammation
Time Frame: Time Points 0-1 days
4. Change in Cornea and iris inflammation
Time Frame: Time Points 0-1 days
Secondary Outcomes
- Not Applicable(Not Applicable)
Investigators
Dr Ishika Gandhi
CCFT Laboratories
Study Sites (1)
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