The purpose of the study is to evaluate safety and performance of Eye Preparations - Sodium Chloride Eye Drop (0.75%) (Calendula extract plus Hamamelis extract
- Conditions
- Cataract in diseases classified elsewhere,
- Registration Number
- CTRI/2022/07/043790
- Lead Sponsor
- STERICON PHARMA PRIVATE LIMITED
- Brief Summary
A post market clinical follow up prospective study to evaluate safety and performance of Eye Preparations (Sodium Chloride Eye Drop (0.75%) (Calendula extract + Hamamelis extract**)**.
Sodium Chloride 0.75% Eye drops with calendula + Hamamelis extract are used to relieve eye discomfort and soreness due to environmental factors Polyhexamethylene biguanide binds to the negatively charged phospholipids found in the microbial plasma membranes causing membrane disruption and cellular lysis. Disodium edetate is a cationic chelating agent that binds free metals and enhances antimicrobial activity of disinfectants. Calendula is having anti-inflammatory properties that help to reduce the irritation of eyes caused by pollutants. It is effective against itching and inflammations of eyes. Hamamelis water is used for external eye preparations such as eye drops and eye wash. It is a Traditional herbal medicinal product for the temporary relief of discomfort due to continuous exposure to wind and sun. Sodium chloride is an electrolyte added to maintain osmolarity as high osmolarity products pull water from epithelial cells.
Sodium Chloride Eye Drop (0.75%) (Calendula extract + Hamamelis extract can be used to protect the eye from irritations/dryness/discomfort due to continuous use of computer/TV/exposed pollution/dry environment and use of contact lenses.
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
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|Intended purpose
Persons who experience irritation, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment use the eye drop with herbal extract to soothe the eyes.
|Intended users
Persons who experience irritation/ itchiness/discomfort of eyes due to the continuous use of computer/TV/ exposed pollution /dry environment.
This study will be a prospective, multi-centric, non-randomized study. The subjects visiting the study centers with the complaints such as eye dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment will be screened at Day 0 and if they meet the inclusion and exclusion criteria, then they will be selected for the study. A total of 72 subjects will be recruited for this study for the Sodium Chloride Eye Drop (0.75%) (Calendula extract + Hamamelis extract).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 72
- 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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to confirm clinical safety and performance of the product Sodium Chloride Eye Drop (0.75%) (Calendula extract + Hamamelis extract) by performing a set of eye examinations (i.e.visual acuity test, IOP measurement, corneal staining, Schirmer’s test considering the baseline from the initial visit and obtained during the follow up visits. If the end user is a contact lens wearer contact lens characteristics will also be measured at the end of the study 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 Outcome Measures
Name Time Method 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 1st Visit - After 8 days of using the product
Trial Locations
- Locations (1)
Vivekananda Eye Hospital, Bengaluru, Karnataka
🇮🇳Bangalore, KARNATAKA, India
Vivekananda Eye Hospital, Bengaluru, Karnataka🇮🇳Bangalore, KARNATAKA, IndiaDr Chethan S SadanandPrincipal investigator9600122287chethan.sadanand@gmail.com