MedPath

Tear free test of Piramals Multiple Baby care products.

Not Applicable
Registration Number
CTRI/2023/11/059515
Lead Sponsor
Piramal Pharma Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
•Change in lacrimation <br/ ><br>•Change in conjunctival inflammation. <br/ ><br>•Change in cornea and iris inflammation . <br/ ><br>Timepoint: [Time frame 0-1 days] <br/ ><br>[Time frame 0-1 days] <br/ ><br>[Time frame 0-1 days] <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
ot applicableTimepoint: Not applicable
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