A Multicenter, Randomized, Double-masked, Controlled, Non-inferiority Study to Evaluate Tolerability, Safety and Efficacy of Lubricin vs Sodium Hyaluronate in Subjects With Moderate Dry Eye.

Detailed Summary

The objective of the clinical investigation was to evaluate tolerability, safety and efficacy of the tested medical device, eye drop containing Lubricin 150 µg/mL, as compared with a standard sodium hyaluronate 0.13% eye drop solution in subjects with moderate dry eye disease. Primary objective: • Symptom Assessment in Dry Eye (SANDE) Secondary objectives: * Treatment-emergent adverse events (TEAEs); * Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia); * Tear film osmolarity; * Assessment of best corrected distance visual acuity (BCDVA) * Slit lamp examination (SLE) to assess the Eyelid - Meibomian glands, Eyelid Erythema, Eyelid Oedema, Lashes, Conjunctiva Erythema, Lens, Iris, Anterior Chamber, Corneal transparency, Corneal neovascularization; * Tear film break-up time (TFBUT); * Corneal fluorescein surface staining (scored using the Oxford scale); * Schirmer-I test (without anaesthesia) values; * Intraocular Pressure (IOP) All parameters will be evaluated at screening visit, baseline (day 1), visit 3 (day 14±2) and visit 4 (day 28±4) and at follow-up (final visit) at least 7 days but not more than 9 days after the last treatment. The results for both the SANDE questionnaire and adverse events are reported at the patient level, without distinguishing between Study Eye and Non-Study Eye. This approach reflects the overall condition and experiences of the patient rather than attributing outcomes to individual eyes. The Study Eye was identified as the eye with the worst overall tolerability score at Visit 2 (Day 1).

Study Details

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Interventions