None listed
Conditions
Interventions
Intervention1: Baby Head To Toe Wash: 10 µl of diluted test product to be instilled into conjunctival sac on one eye.
Single usage of product.
Control Intervention1: Distilled water: 10 µl of control
Sponsors
Uprising Science Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy adult non-pregnant/non-lactating females with age 18 to 65 years (both inclusive) at the time of consent. 2. Subjects in general good health as determined by the Investigator on the basis of medical history and with no medical conditions of the eye. 3. Subjects who pass a general eye examination as assessed by Ophthalmologist. 4. Subjects who pass an eye sting evaluation using isotonic saline and an Ophthalmologist Eye evaluation as assessed by Ophthalmologist. 5. Subjects having visual acuity of at least 20/40 (with corrective wear, i.e., glasses but not contact lens).
Exclusion criteria
Exclusion criteria: 1. Subjects wearing any facial and eye makeup including false eye lashes on the day of the study visits. 2. Subjects currently using or have used eye drops (e.g., Visine, Saline Solutions, etc.) within the last 2 weeks. 3. Subjects who ever had any eye conditions such glaucoma, cataracts, exophthalmos (protuberance of eye), etc. 4. Subjects having any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within 2 weeks of the study. 5. Subjects who had any eye surgery (including Lasik, laser eye surgery). 6. Subjects having any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ophthalmological assessment of Ocular Tolerance of the test product (i.e., degree of inflammation of bulbar and palpebral conjunctiva and lacrimation).Timepoint: Day 01 (30 secs, 3 mins, 5 mins, 10 mins, 15 mins and 60 mins after instillation) Day 02 (24 hrs after instillation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of self-perceived discomfort using 4-point scale by subjects.Timepoint: Day 01 (30 secs, 15 mins and 60 mins after instillation) Day 02 (24 hrs after instillation) | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed