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

NCT03031327 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-06

Study results available
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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).

Conditions

  • Ocular Discomfort

Interventions

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

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Flavio Mantelli, MD-PhD · Dompé Farmaceutici S.p.A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-17
Primary Completion
2017-08-10
Completion
2017-08-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03031327 on ClinicalTrials.gov