None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ages 6-12 years both inclusive. 2.Subjects are in general good health and has both eyes. 3.The child s mothers understand the test procedures and agree to adhere to study requirements, instructions and procedures. 4.The child passes an eye sting evaluation using isotonic saline. 5.Subject s mothers are willing to refrain from using any eye drops on the day of the study.
Exclusion criteria
Exclusion criteria: 1.Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc.). 2.Have participated in a study with the eyes as the target area within 6 weeks of the start of the study. 3.Be involved in any aspect of study administration, i.e., evaluating applying products, etc. 4.Have a history of sensitivity and/or adverse reactions to preparations intended for the eyes. 5.Subject currently having any eye infections or irritation. 6.The subject is having any sensitivity to eye make-up. 7.Currently have any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study. 8.Currently using any topical medications on the face or any medications intended for the eyes. 9.Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) on the days of the study. 10.Have any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results. 11.Currently taking any prescription pain medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the irritation and stinging/discomfort effect of the test product as compared to control with both subjective sting/irritation and objective evaluations. 2.To assess the visual effect i.e., degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, and lacrimation of test product as compared with the control. 3.To evaluate the effectiveness of the test product in subject perception questionnaire.Timepoint: At Baseline Day 01 and Day 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
NovoBliss Research Private Limited