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Evaluation of MAF-1217 in Patients With DED

NCT03833882 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-07-15

No results posted yet for this study

Summary

This is a pre-market, multicentre, double-blind, randomized, crossover, non-inferiority study comparing the efficacy of MAF-1217 and Cationorm® in adult patients with evaporative DED.

The study population will be divided in 4 different subgroups, according to the different types of evaporative DED:

1. Group A: high evaporative levels
2. Group B: females in menopause, whether using hormonal integration or not
3. Group C: presence of active obstructive Meibomian gland disease
4. Group D: glaucomatous patients

Conditions

  • Evaporative Dry Eye Disease

Interventions

DEVICE

MAF1217

The study population will have to self-administer the study treatment in a TID posology.

OTHER

Cationorm

The study population will have to self-administer the study treatment in a TID posology.

Sponsors & Collaborators

  • VISUfarma SpA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2019-06-19
Completion
2019-06-19

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 NCT03833882 on ClinicalTrials.gov