A clinical study to evaluate the test products for â??No Tearâ?? on adult male and female subjects by eye-instillation technique
- Registration Number
- CTRI/2020/11/029145
- Lead Sponsor
- Dabur India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Assessment for eye irritation <br/ ><br>2. Assessment for tear formation <br/ ><br>3. Assessment for Subjective discomfort <br/ ><br>Timepoint: Screening Visit, Baseline Visit, Visit 1, Visit 2, Visit 3 & Visit 4
- Secondary Outcome Measures
Name Time Method To evaluate the product acceptance & toleranceTimepoint: Screening Visit, Baseline Visit, Visit 1, Visit 2, Visit 3 & Visit 4