A post market clinical follow up prospective study to evaluate safety and performance of Hydroxypropyl Methylcellulose 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 and 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 50 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 Hydroxypropyl Methylcellulose Eye Drops. The allocation of Hydroxypropyl Methylcellulose Eye Drops will be subjected to eye dryness by the PI. They will be followed up 3 times on Day 15, Day 30 and Day 60 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.

Result-

The observational, prospective, open-label, single-arm, single-center, non-randomized PMCF study evaluated the clinical safety and performance of Hydroxypropyl Methylcellulose Eye Drops in 50 subjects over 60 days. All participants completed three follow-ups, and no adverse events, residual risks, or contraindications were reported. Corneal staining was consistently normal (grade 0), with no superficial keratitis observed. Mean intraocular pressure, visual acuity and safety parameters remained stable and within normal ranges, confirming no adverse ocular effects. Schirmer’s test values improved from 16.86 mmHg (right eye) and 17.1 mmHg (left eye) at baseline to 22.32 mmHg and 23.54 mmHg at day 60, while TBUT increased from 4.18s and 4.02s to 6.32s and 6.64s, respectively, indicating enhanced tear secretion and stability. Performance outcomes demonstrated high efficacy, with 45 subjects reporting relief from dry eyes, 48 reporting reduced irritation, and all 50 noting improved comfort and relief from burning sensations, particularly during screen use. Clinical benefits included moisturizing, soothing, and refreshing effects, with a sustained action lasting over two hours. Satisfaction was high—23 subjects rated the product excellent and 27 rated it good as per PI assessment, while subject ratings on day 60 showed 34 excellent and 16 good. Overall, the product was well-tolerated, improved ocular comfort and visual quality, and was easy to use as per IFU, confirming both safety and clinical benefit in daily use.