CTRI

Hypromellose +Sodium Hyaluronate eye drops are used to relieve eye discomfort and soreness due to environmental factors. They moisten, soothe and lubricate the surface of the eye, making it feel more comfortable. Hypromellose provides lubrication to the ocular surface and maintaining corneal hydration in dry eye conditions. The viscosity promoting properties of hypromellose prolong the retention time and improve adhesion of synthetic tears to the cornea and conjunctiva. Sodium hyaluronate is a derivative of hyaluronic acid. 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.

Polyhexamethylene biguanide binds to the negatively charged phospholipids found in the microbial plasma membranes causing membrane disruption and cellular lysis. Phosphate buffer (disodium hydrogen phosphate & Sodium dihydrogen phosphate dihydrate).Sodium phosphate, buffer, is the most physiologic of all the common buffers, as itâ€™s a natural buffer occurring in tears.

Hypromellose +Sodium Hyaluronate 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

Intended purpose	Persons who experience dryness, Itchiness, discomfort of eyes due to the continuous use of computer/TV/exposed pollution/dry environment use the eye drops to soothe the eyes.
Intended users	Persons who experience dryness/itchiness/discomfort of eyes due to the continuous use of computer/TV/ exposed pollution /dry environment.

Results-

A PMCF study of Hypromellose + Sodium Hyaluronate Eye Drops was conducted at Marigold Hospital, Bangalore, in 54 subjects (29 male, 25 female; aged 18–50 years), including 3 contact lens wearers. The target population included individuals experiencing ocular irritation, itching, discomfort, redness, watering, or strain due to prolonged computer/TV use, pollution, or dry environments. Corneal staining remained normal (grade 0) throughout the study, while intraocular pressure (IOP) and visual acuity (UNDVA, BCDVA) showed no significant variation from baseline (p>0.05), confirming ocular safety. Schirmer’s test and TBUT demonstrated statistically significant improvements in tear film stability and eye moisture, supporting clinical efficacy; results were consistent across gender and age groups. Clinical safety was further supported by the absence of adverse events, complications, or residual risks during the 90-day follow-up.

Subjects consistently reported improvements in comfort, lubrication, moisturization, and soothing effects, with relief lasting 2–5 hours post-instillation. Contact lens wearers showed no changes in lens base curve, power, or diameter, confirming compatibility with lens use. Potential misuse scenarios (e.g., non-adherence to IFU,improper storage, off-label use) were identified but not observed in this study. The benefit–risk ratio was favorable, with no new risks identified beyond those in the existing RMF. Overall satisfaction ratings from both the principal investigator and subjects were “good” (average score 3), with participants reporting relief from soreness and irritation, improved visual comfort, and better quality of daily activities.

In conclusion, Hypromellose + Sodium Hyaluronate Eye Drops demonstrated an excellent safety, efficacy, and performance profile in real-world use, with high patient and investigator satisfaction, supporting its continued safe clinical use.