To test the cosmetic safety by assessing the eye irritation and also to assess the no eye tears in healthy male and female human volunteers.
- Registration Number
- CTRI/2022/01/039626
- Lead Sponsor
- Vishal Mega Mart Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. No medical condition of the eye as determined by the subjects medical history.
2. Subjects not under doctors care for ocular or periorbital 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
4. Subject is willing to provide the informed consent
5. Subject having not participated in a similar investigation in the past one month.
6. Subjects ready to follow instructions during the study period.
1. Conjunctival corneal conditions and periocular area conditions,
2. Use of contact lenses,
3. Pregnancy/lactation, and other diseases or medications that may directly interfere in the study or endanger the subjectââ?¬•s health.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Ophthalmic Scoring Scale (Slit Lamp Biomicroscope Examination) 1) Lacrimation 2) Eyelid Irritation 3) Palpebral Conjunctival Irritation 4) Bulbar Conjunctival Irritation using 5) Corneal Abnormalities (opacities, edema, infiltrates, vascularization, and/or epithelial defects) using 0-4 scaleTimepoint: Up to 120 min
- Secondary Outcome Measures
Name Time Method Subjective Opthalmic scoring scale (Irritation scoring- Stinging, Burning, Itching, dryness and or foreign body sensationTimepoint: Up to 120 min;To assess the adverse eventsTimepoint: 7 days