A 2 Weeks, Randomized, Double-masked, Controlled Study to Assess Tolerability, Safety, Permanence on the Ocular Surface, Efficacy of Lubricin (20 and 50 μg/ml) vs Sodium Hyaluronate 0.18% in Ocular Discomfort Following Refractive Surgery.

Detailed Summary

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).

Study Details

Timeline

Interventions