None listed
Conditions
Interventions
Intervention1: Baby Wash: Single instillation of 15 microliters of 10 percent diluted randomized test product in the randomized eye and distilled water in the other eye
Intervention2: Baby Shampoo: Si
Sponsors
Mother Sparsh Baby Care Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with no medical conditions of the eye as determined by the subjects medical history and confirmed by the ophthalmologist. 2. Subjects not under any doctors care for or peri orbital diseases. 3. Subjects willing to refrain from using any topical facial products, any eyedrops, 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. Subjects in good health and willing to provide written informed consent and attend regular follow-up visits. 5. Subjects willing to comply with the study protocol and refrain from participating in any other clinical study during the current study.
Exclusion criteria
Exclusion criteria: 1. Subject with conjunctival, corneal, or periocular conditions, orthose using contact lenses. 2. Subject with known history or present allergic condition that may require medical attention. 3. Subject with chronic illness which may influence the cutaneous assessment. 4.Subjects on any systemic medication or with birth defect and anomalies. 5. Subjects with a past or present history of significant ophthalmological disease or conditions, or those judged by the investigator to be inappropriate for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in the ocular irritation potential as per Ophthalmologist assessment.Timepoint: 0 hour, 30 seconds, 15 minutes, 60 minutes, 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the ocular reaction as per Ophthalmologist assessment on using the test product.Timepoint: 0 hour, 30 seconds, 15 minutes, 60 minutes, 24 hours;Mean change in the ocular irritation severity scores as per subjects assessment on using the test product.Timepoint: 0 hour, 30 seconds, 15 minutes, 60 minutes, 24 hours | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed