A post market clinical follow up prospective study to evaluate safety and performance of Sodium Hyaluronate 0.2% Eye Drops

This study will be an open-label, single-armed, single-centric, observational, prospective PMCF study. The subjects visiting the study center with the complaints such as eye dryness, eye soreness/ burning, irritative sensation, eye fatigue, contact lens caused dryness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment will be screened on Day 0 and if they meet the inclusion and exclusion criteria, then they will be selected for the study. A total of 53 subjects will be recruited for this study, subjects will be undergoing visual acuity test, IOP, corneal staining, Superficial Keratitis, TBUT test, Schirmer’s test. After the consent is signed these subjects will be given Sodium Hyaluronate 0.2% Eye Drops. The allocation of Sodium Hyaluronate 0.2% Eye Drops will be subjected to eye dryness by the PI. They will be followed up for 4 times on Day 8th , Day 30th, Day 60th and Day 90th after using the product. At every follow up visit the above-mentioned test, comprehensive eye examination by the Investigator will be performed and apart from these performance and safety tests, benefits, risks, side effects and adverse events will be recorded.

Results-

This prospective, observational, single-centre PMCF study evaluated the safety and performance of Sodium Hyaluronate 0.2% Eye Drops in 52 subjects, followed up on Day 8, 30, 60, and 90. Assessments included visual acuity, IOP, corneal staining, Schirmer’s test, and TBUT. Results showed no significant changes in visual acuity or IOP, normal corneal staining at Day 90, and statistically significant improvements in both Schirmer’s test and TBUT, confirming increased eye moisture and tear film stability. Overall, subjects reported improved comfort and visual performance. No serious adverse events occurred; two subjects discontinued on Day 8 due to mild itching, redness, and pricking sensation, likely related to sodium perborate allergy, and both recovered after antihistamine treatment. No residual risks were observed, confirming that the product is safe, effective, and well tolerated with a favorable benefit–risk profile.