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Tear free test for Piramals Littles organic syndent soap

A Single blind Clinical study to evaluate the eye stinging potential of Piramal’s Littles Organix Syndet Soap. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/06/068765
Enrollment
30
Registered
2024-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

None listed

Interventions

Intervention1: Littles Organix Syndent Soap: 1.Littles Organix Syndent Soap Route of Administration: Topical Duration: 1 hour Frequency: Once Control Intervention1: Not Applicable: Not Applicable

Sponsors

Piramal Pharma Limited
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.org8937015757

Outcome results

None listed

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