The objective of this study is to evaluate tolerability, safety and efficacy of Lubricin 150 µg/ml eye drops when compared to a widely used commercial 0.18% sodium hyaluronate eye drop formulation in moderate dry eye patients. Primary objectives: * Tolerability using a Visual Analogue Scale (VAS) for foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision, and photophobia; * Treatment-emergent adverse events (TEAEs), assessed throughout the clinical investigation. Secondary objectives: * Corneal fluorescein staining (scored using the Oxford scale); * Schirmer test type I (without anaesthesia); * Symptom assessment in dry eye (SANDE); * Ocular protection index (OPI); * Tear film break-up time (TFBUT); * Best corrected distance visual acuity (BCDVA); * Slit lamp examination (SLE) (Eyelid - Meibomian glands, eyelid erythema, eyelid oedema, lashes, conjunctiva erythema, lens, iris, anterior chamber, corneal transparency, corneal neovascularisation); * Intraocular pressure (IOP); * Number of instillations of investigational medical device during the second week of the clinical investigation. All parameters will be evaluated at Screening visit-V1 (Day -7 up to day -5), baseline visit-V2 (Day 1), V3 (Day 7±1), V4 (Day 14±1) and at Final Visit follow-up-V5 (Day 21±1).
Age range
18 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change From Baseline in Foreign Body Sensation, Burning/Stinging, Itching, Pain, Stick Feeling, Blurred Vision, Photophobia and Total Ocular Tolerability Score (VAS)
Timeframe: Visit 3 - Day 7±1, Visit 4 - Day 14±1 and Visit 5/Final visit/Follow up - Day 21±1
Treatment-emergent Adverse Events (TEAEs), Assessed Throughout the Study.
Timeframe: Visit 5/Final visit/Follow up - Day 21±1