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Tear free test of Piramal Little Aquasense Baby Wipes and Littles Soft Cleansing Baby Wipes

A Single blind Clinical study to evaluate the eye stinging potential of Piramal Little Aquasense Baby Wipes and Littles Soft Cleansing Baby Wipes - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/106550
Enrollment
32
Registered
2026-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Test Product: 1.Little Aquasense Baby Wipes 2.Littles Soft Cleansing Baby Wipes: Test Product: 1.Little Aquasense Baby Wipes 2.Littles Soft Cleansing Baby Wipes Route of Administration:

Sponsors

Piramal Pharma Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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 2. Subjects not under any doctor care for ocular or peri orbital diseases. 3. 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

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.

Design outcomes

Primary

MeasureTime frame
1.Change in lacrimation 2.Change in conjunctival inflammation. 3.Change in cornea and iris inflammation .Timepoint: Time Points 0-1 days Time Points 0-1 days Time Points 0-1 days

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactPuneet Mittal

CCFT Laboratories

puneetmittal@mgcts.org08937015757

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026