CTRI/2022/07/043790
Completed
Phase 4
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (Sodium Chloride Eye Drop (0.75%) (Calendula extract plus Hamamelis extract)
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: H28- Cataract in diseases classified elsewhere
- Sponsor
- STERICON PHARMA PRIVATE LIMITED
- Enrollment
- 72
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 with herbal extract from the PI/CO\-I by a medical practitioner. The inclusion criteria for the subjects for this study are as follows:
- •\-Subjects who experience, 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
- •The below Subjects are excluded from the study:
- •\-Subjects who are not willing to participate in the study
- •\-Anyone with known allergic reaction to Sodium Chloride Eye Drop (0\.75%) (Calendula extract \+ Hamamelis extract)
- •\-Subjects with any existing eye infection
- •\-Subjects undergone recent (6weeks) cataract surgery who are on other eye medication
Outcomes
Primary Outcomes
Not specified
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