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A clinical study to evaluate the test products for â??No Tearâ?? on adult male and female subjects by eye-instillation technique

A clinical study to evaluate the irritation potential of the test products in support of â??No Tearâ?? on adult male and female subjects by eye-instillation technique

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029145
Enrollment
35
Registered
2020-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Dabur baby wash- 155/086, Dabur baby shampoo-155/087, Dabur baby shampoo-155/089: The study will be conducted for a period of approximately 6 days for each subject and will include a to

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male/female subjects in the age group of 18-55 years. 2. Subjects in general good health as determined from a recent medical history. 3. Subjects willing to give a voluntary written informed consent and agree to come for regular follow up. 4. Subjects willing to abide by and comply with the study protocol. 5. Subjects should not participate in any other clinical study during participation in the current study

Exclusion criteria

Exclusion criteria: 1. Subjects with eye infection 2. Subjects with dry eyes 3. Subjects who are contact lens users. 4. Subjects with a known history or present condition of allergic response to any other concern that may require medical attention. 5. Subjects with chronic illness which may influence the cutaneous state. 6. Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data. 7. Subject allergic or sensitive to bar cleansing products, creams/lotions or anything else. 8. Subject pregnant or nursing. 9. Subjects with any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness

Design outcomes

Primary

MeasureTime frame
1. Assessment for eye irritation 2. Assessment for tear formation 3. Assessment for Subjective discomfort Timepoint: Screening Visit, Baseline Visit, Visit 1, Visit 2, Visit 3 & Visit 4

Secondary

MeasureTime frame
To evaluate the product acceptance & toleranceTimepoint: Screening Visit, Baseline Visit, Visit 1, Visit 2, Visit 3 & Visit 4

Countries

India

Contacts

Public ContactRitambhara

Dabur India Limited

sasibhushan.vedula@dabur.com01203378404

Outcome results

None listed

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