Study is to evaluate safety and performance of Eye Preparations- Sodium Hyaluronate (0.1%, 0.2%, 0.3%, and 0.4%) Eye Drops.
Phase 4
Completed
- Conditions
- Health Condition 1: H28- Cataract in diseases classified elsewhere
- Registration Number
- CTRI/2022/07/043786
- Lead Sponsor
- STERICON PHARMA PRIVATE LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 282
Inclusion Criteria
Subjects who experience dryness, 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 comfort/TV/exposed pollution/dry environment.
Exclusion Criteria
-Subjects who are not willing to participate in the study
-Anyone with known allergic reaction to HA eye drops
-Subjects with existing eye infection
-Subjects undergone recent (6 weeks) 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 hyaluronate (eye drop) by performing a set of eye examinations (i.e. visual acuity test, IOP measurement, corneal staining, TBUT test, Schimer’s Test) considering the baseline from the initial visits and the data 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. <br/ ><br> <br/ ><br>Timepoint: 1st Visit - After 8 days of using the product <br/ ><br>2nd Visit - After one month of using the product <br/ ><br>3rd Visit - After two months of using the product <br/ ><br>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 for prolonged period to ensure acceptability of benefit risk ratio of the Eye drop, 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. <br/ ><br> <br/ ><br>Timepoint: 1st Visit - After 8 days of using the product <br/ ><br>2nd Visit - After one month of using the product <br/ ><br>3rd Visit - After two months of using the product <br/ ><br>4th Visit - After three months of using the product