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Tolerability, Safety and Efficacy of Lubricin vs Sodium Hyaluronate Eye Drops in Subjects With Moderate Dry Eye

NCT02510235 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-02-26

Study results available
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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).

Conditions

  • Dry Eye Syndrome
  • Tear Film Insufficiency

Interventions

DEVICE

Lubricin

Lubricin 150 µg/ml eye drops

DEVICE

Sodium Hyaluronate

Sodium hyaluronate 0.13% eye drops

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Flavio Mantelli, MD · Dompé farmaceutici

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-09
Primary Completion
2015-06-10
Completion
2015-06-18

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 NCT02510235 on ClinicalTrials.gov