NCT02507934

Tolerability, Safety and Efficacy of Lubricin Versus Sodium Hyaluronate Eye Drops in Patients With Moderate Dry Eye

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study is a 2 week, randomized, double-masked, controlled, parallel group and 1 week follow-up investigation to evaluate tolerability, safety and efficacy of Lubricin (150 µg/mL) eye drops versus sodium hyaluronate (HA) 0.18% eye drops (Vismed®) in patients with moderate dry eye (DE).

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DEVICE	Lubricin	Lubricin 150 µg/ml eye drops
DEVICE	Sodium Hyaluronate	Sodium hyaluronate 0.18% eye drops

Timeline

• Start date: 2015-06-26
• Primary completion: 2015-10-05
• Completion: 2015-10-06
• First posted: 2015-07-24
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

1 site across 1 country: Italy