Health Condition 1: H28- Cataract in diseases classified elsewhere
Conditions
Interventions
Intervention1: EYE PREPARATIONS - EYE WASH WITH HERBAL EXTRACT /DISTILLED WITCH HAZEL EYE WASH: Eye drops soothes and gives comfort to the eyes.To apply the Eye wash with Herbal extract:
?Rinse Eye b
Sponsors
Stericon Pharma Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: At the time of screening and usage of the product all subjects must meet the following criteria for inclusion into the study and the subjects will receive the prescribed eye wash from the PI/CO-PI by a medical practitioner. The inclusion criteria for the subjects for this study are as follows: -Subjects who experience irritation, soreness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment
Exclusion criteria
Exclusion criteria: The below Subjects are excluded from the study: -Subjects who are not willing to participate in the study -Anyone with known allergic reaction to Eye wash with Herbal extract/Distilled witch Hazel Eye Wash -Subjects with allergic reaction to any eye medication or any existing eye infection -Subjects undergone recent (6 weeks) cataract surgery who are on other eye medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to confirm clinical safety and performance of the product Eye wash with herbal extract by Distilled Witch Hazel eye wash performing a set of eye examinations (i.e. -visual acuity test, IOP measurement considering the baseline from the initial visit and obtained during the follow up visitsTimepoint: There will be 4 follow up visits expected after using the product: 1st Visit - After 8 days of using the product 2nd Visit - After one month of using the product 3rd Visit - After two months of using the product 4th Visit - After three months of using the product | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to assess any emerging undesirable events along with monitoring of desired events, contraindications, residual risk, emerging risk under normal usage of the eye wash with herbal extract for prolonged period to ensure acceptability of benefit risk ratio of the Eye wash with herbal extract, which will be recorded in CRF during every follow up visit based on the subject rating. The study will be focused on identifying possible systematic misuse or off-label use of the device.Timepoint: There will be 4 follow up visits expected after using the product: 1st Visit - After 8 days of using the product 2nd Visit - After one month of using the product 3rd Visit - After two months of using the product 4th Visit - After three months of using the product | — |
Countries
India
Contacts
Public ContactDr Chethan S Sadanand
Vivekananda Eye Hospital,Bengaluru,Karnataka
Outcome results
None listed