Safety and Efficacy of 2 Concentrations of Lubricin vs Sodium Hyaluronate in Ocular Discomfort After Refractive Surgery.

The objective of this study was to evaluate tolerability, safety, permanence on the ocular surface and efficacy of Lubricin (20 and 50 μg/mL) eye drops vs Sodium Hyaluronate (Vismed®) 0.18% eye drops in patients with ocular discomfort following refractive surgery. Primary objectives: * Tolerability using a Visual analogue scale (VAS) for dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia; * Treatment-emergent adverse events (TEAEs), assessed throughout the study. Secondary objectives: * Ocular surface vital staining with Fluorescein (Oxford scale) * Schirmer-I test (without anaesthesia); * Permanence of Lubricin on the Ocular Surface Tear film break-up time (TFBUT); * Best corrected distance visual acuity (BCDVA); * SANDE questionnaire scores - discomfort improvement entity; * SANDE questionnaire scores - discomfort improvement speed; * Signs evaluated by Slit lamp examination (SLE) (blepharitis, eyelid hyperemia/oedema, lashes, conjunctiva hyperemia); * Intraocular pressure (IOP) ; * Corneal sensitivity by Cochet-Bonnet aesthesiometry. All parameters were evaluated at V1 (Day 1 - Baseline), V2 (Day 15±2) and V3 (Day 22±2/ETV).