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Assessment of Efficacy and Safety of the Use of Two Eye Gel Products Containing 5% Dexpanthenol in Patients With Moderate to Severe Dry Eye Syndrome

NCT06210373 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2024-07-29

No results posted yet for this study

Summary

The prospective, multicentric, randomized, non-inferiority, controlled, open-label clinical investigation will evaluate the efficacy and safety of the use of Myrialen® gel vs.

Recugel®, two eye gel products containing 5% dexpanthenol, in patients with moderate to severe dry eye syndrome.

A total of 110 evaluable patients (55 in each treatment group), ≥18 years of age, will be required for data analysis. A total of 124 patients (62 in each treatment group) will be randomized to replace potential early withdrawals or non-evaluable patients.The primary objective of this investigation is to demonstrate non-inferior efficacy of Test Myrialen® gel over the Reference Recugel® in improving corneal and conjunctival surface state, assessed through slit lamp biomicroscopy examination, in patients with moderate to severe dry eye syndrome.

Conditions

Interventions

DEVICE

Myrialen Gel

Myrialen Gel will be instilled as 1 drop per eye 3 times a day and one drop per eye before going to bed in the conjunctival sac for 30 days.In case of bilateral dry eye syndrome, both eyes will be treated. In case of monolateral dry eye syndrome, the decision to treat both eyes will be taken according to the Investigator's judgment.

DEVICE

Recugel

Recugel will be instilled as 1 drop per eye 3 times a day and one drop per eye before going to bed in the conjunctival sac for 30 days. In case of bilateral dry eye syndrome, both eyes will be treated. In case of monolateral dry eye syndrome, the decision to treat both eyes will be taken according to the Investigator's judgment.

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Principal Investigators

  • Leonardo Mastropasqua, MD · Ospedale SS. Annunziata- Università degli studi G. d'Annunzio-Chieti

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-16
Primary Completion
2024-11-30
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

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 NCT06210373 on ClinicalTrials.gov