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Clinical Trials/CTRI/2025/08/093833
CTRI/2025/08/093833
Not yet recruiting
Post Marketing Surveillance

A Single Blind Clinical Study to evaluate the Eye Stinging Potential of Purite Baby 3 in 1 TF010625 on healthy human volunteers

Marico South East Asia Corporation1 site in 1 country32 target enrollmentStarted: September 10, 2025
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Overview

Phase
Post Marketing Surveillance
Status
Not yet recruiting
Sponsor
Marico South East Asia Corporation
Enrollment
32
Locations
1
Primary Endpoint
1. Change in Discomfort
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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 Purite Baby 3 in 1 TF010625

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 65 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 t1min, t2min, t5min

2. Change in Lacrimation

Time Frame: Time Points t1min, t2min, t5min

3. Change in Conjunctival inflammation

Time Frame: Time Points t1min, t2min, t5min

4. Change in Cornea and iris inflammation

Time Frame: Time Points t1min, t2min, t5min

Secondary Outcomes

  • Not Applicable(Not Applicable)

Investigators

Sponsor
Marico South East Asia Corporation
Sponsor Class
Pharmaceutical industry-Global
Responsible Party
Principal Investigator
Principal Investigator

Dr Ishika Gandhi

CCFT Laboratories

Study Sites (1)

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