NCT03031327

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Dompé Farmaceutici S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study was a 2 week randomized (1:1:1), controlled, double-masked, parallel group, pre-market study 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.

Conditions

• Ocular Discomfort

Interventions

Type	Name	Description
DEVICE	Lubricin 20µg/ml	Lubricin 20µg/ml eye drops
DEVICE	Lubricin 50µg/ml	Lubricin 50µg/ml eye drops
DEVICE	Sodium hyaluronate 0.18%	Sodium hyaluronate (HA) 0.18% eye drops

Timeline

• Start date: 2017-06-17
• Primary completion: 2017-08-10
• Completion: 2017-08-10
• First posted: 2017-01-25
• Last updated: 2024-12-06
• Results posted: 2024-12-06

Locations

1 site across 1 country: Italy