2 Week, Randomized, Double-masked, Controlled, Parallel Group+1 Week Follow-up Study to Evaluate Tolerability, Safety and Efficacy of Lubricin 150 µg/ml vs Sodium Hyaluronate (HA) 0.18% Eye Drops (Vismed®) in Patients With Moderate Dry Eye

Detailed Summary

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).

Study Details

Timeline

Interventions