None listed
Conditions
Interventions
Intervention1: R For Rabbit Biomimic Shampoo: Marketed by: R For Rabbit Baby Products Pvt Ltd
Route of Application: Topical
Mode of Usage: Apply an adequate amount of shampoo to wet hair and scalp. Ge
Sponsors
R For Rabbit Baby Products Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Ages 18-65 years both inclusive. 2.Sex: Males and non-pregnant or non-lactating females 3.Females with self-reported negative pregnancy test. 4.The study Participant is in general good health and has both eyes. 5.Understand the test procedures and agree to adhere to study requirements, instructions and procedures. 6.Pass a general eye evaluation as assessed by trained clinicians/ophthalmologists. 7.Pass an eye sting evaluation using isotonic saline. 8.Study participants 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 worn contact lenses during the study period. (12 months). 3. Have any of the following conditions or factors that may affect the interpretation of the test results, including but not limited to, diabetes (controlled or uncontrolled), currently pregnant, or currently lactating or have lactated within the last 4 months. 4. Have participated in a study with the eyes as the target area within 6 weeks of the start of the study. 5. Be participating in any other study concurrently. 6. Be involved in any aspect of study administration, i.e., evaluating applying products, etc. 7. Have a history of sensitivity and/or adverse reactions to preparations intended for the eyes. 8. Ever had any eye conditions such as glaucoma, cataracts, exophthalmos (protuberance of the eye), etc. 9. Subject currently having any eye infections or irritation. 10. The subject is having any sensitivity to eye make-up. 11. Currently have any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study. 12. Ever had any eye surgery (including Lasik, laser eye surgery). 13. Currently using any topical medications on the face or any medications intended for the eyes. 14. Be wearing any facial makeup, including false eyelashes, on the day of the study visits. 15. Consume any alcoholic beverages during the days of the study. 16. Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) or analgesics (including aspirin or other over-the-counter analgesics) on the days of the study. 17. 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. 18. Currently taking any prescription pain medications. 19. Have smoked within 1 hour during the study visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To assess the ocular irritation and stinging/discomfort effect of the test product as compared to control with both subjective and objective evaluations before and after instillation. 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 before and after instillation. 3.To assess the safety and efficacy of test products by subjective perception questionnaire after instillation. Timepoint: Baseline and post instillation at 30 seconds, 15 minutes and 60 minutes on day 01 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed