Health Condition 1: H28- Cataract in diseases classified elsewhere
Conditions
Interventions
Intervention1: SODIUM CHLORIDE 0.5% EYE DROPS (CHAMMOMILE EXTRACT plus EUPHRASIA EXTRACT)(PRESERVATIVE FREE): Eye drops soothes and gives comfort to the eyes.
Preservative Free Eye Drops with Chamomil
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 drops 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 , Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment -Subjects wearing contact lenses who experience dryness, 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 Preservative Free Eye Drops with Chamomile and Euphrasia extract -Subjects with 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 Sodium Chloride 0.5% eye drops with Borate and Citrate buffer (eye drop with herbal extract) by performing a set of eye examinations.Timepoint: 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 drops with herbal extract for prolonged period to ensure acceptability of benefit risk ratio of the eye drop 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: 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 ContactDrChethan S Sadanand
Vivekananda Eye Hospital,Bengaluru,Karnataka
Outcome results
None listed