CTRI

Sodium hyaluronate with Euphrasia extract eye drops 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. Sodium hyaluronate has water retaining properties and provides a low resistance to blinking. It is highly effective at entrapping water and preventing evaporation; this prolongs any beneficial effects. Sodium Hyaluronate (SH) is a glycosaminoglycan, present in natural tears, with excellent viscoelastic; lubricating and water retention properties. Its retention time on the ocular surface is high. HA spreads easily and evenly over the ocular surface, providing effective lubrication in very dry/irritated eyes. Disodium edetate is a cationic chelating agent that binds free metals and enhances antimicrobial activity of disinfectants. Euphrasia has antimicrobial effect. Helps treating the eyes. Euphrasia is used in eye baths and eye drops, for watery, reddened and irritated eyes, for swollen eyelids, for sticky eyes in the morning and against tired, overstrained eyes. Boric Acid to create a stable balance that resists changes in the solutionâ€™s pH, Sodium chloride is an Electrolyte added to maintain osmolarity as high osmolarity products pull water from epithelial cells.

Sodium hyaluronate with Euphrasia extract eye drops 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:

1^st Visit - After 8 days of using the product

2^nd Visit - After one month of using the product

3^rd Visit - After two months of using the product

4^th Visit - After three months of using the product

Result-

In this PMCF activity, feedback was collected on 72 subjects, comprising 37 males (54%) and 35 females (46%). Of these, one subject each dropped out on day 30 and day 60 due to eye redness and irritation, while six subjects discontinued on day 60 as they were unwilling to continue. The age distribution showed 11 subjects below 25 years, 45 subjects between 25–45 years, and 16 subjects between 46–65 years. The target population consisted of individuals experiencing irritation, itchiness, and discomfort of the eyes caused by continuous use of computers/TV, exposure to pollution, or dry environments. The study was conducted at Nalam Homoeo Clinic & RC, Krishnagiri, Tamil Nadu, using Sodium Hyaluronate with Euphrasia Extract Eye Drops.

Corneal staining assessments at all visits indicated no changes from baseline, confirming no adverse effects on the cornea. The most common ocular conditions among participants included dryness, itching, strain, redness, discomfort, tiredness, watering, and burning. Safety evaluation showed that eye irritation was reported in 18 subjects and redness in 1 subject at day 30; however, irritation reduced to 9 subjects by day 60 and to 8 subjects by day 90. Intraocular pressure (IOP) remained stable with no significant variation from baseline (p>0.05) and was unaffected by the eye drops. Gender showed no significant effect on IOP, though age had a statistically significant effect (p<0.05). Overall, no major safety issues were observed, and subjects benefitted from the use of the product.

Clinical performance outcomes demonstrated improvement in soothing effect, comfort,moisturization, and refreshed eyes, along with enhanced visual performance. UNDVA values showed no significant change (p>0.05), with gender having no effect, although visual acuity was significantly better in subjects aged smaller or equal 30 years. The median BCDVA remained stable within the normal range from baseline to day 90. Schirmer’s test confirmed an improvement in eye moisture, with statistical significance in the left eye, though no significant change was observed in the right eye. Younger subjects (smaller or equal 30 years) showed comparatively better values.

Mild side effects were reported, including transient eye burning, irritation, and redness. Forty-seven subjects experienced irritation lasting less than a minute at initial use. Residual risks, including eye irritation and watering, were observed in 1 subject on day 8 and in 23 subjects on day 30, reducing to 8 subjects by day 60 and 90. Complaint investigation and root cause analysis confirmed that the product met manufacturing and quality specifications, with possible causes linked to user allergy or improper usage. These events were non-serious and did not lead to major safety concerns. No off-label use or misuse was reported during the 90-day follow-up.

Clinical benefits included comfort, relief from soreness, and lasting effect of 5–8 hours up to a full day, with most subjects confirming the product’s effectiveness. The benefit–risk ratio was favorable, with observed discomfort being mild and transient, while benefits such as improved comfort and relief outweighed residual risks. No new risks were identified beyond those already captured in the RMF. Overall product satisfaction, as rated by the PI, was good with an average score of 3. Subjects reported feeling refreshed, comfortable, and relieved from sore/irritated eyes on days 8, 30, 60, and 90. The overall subject experience score was 3, with improvements in comfort and vision quality leading to better daily activities. This confirms both the safety and effectiveness of Sodium Hyaluronate with Euphrasia Extract Eye Drops.