MedTrace Logo

Study on Safety and Performance of an Artificial Tear in Dry Eye Treatment in Subjects With Ocular Surface Inflammation

NCT04633863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-02

No results posted yet for this study

Summary

This is post-market study to evaluate the safety and efficacy of MDI - 101 a novel tear substitute for the treatment of dry eye (DE) in subjects with evidence of inflammation of the ocular surface. In particular, this study intends to evaluate, in a cohort of 25 patients, the anti-inflammatory properties of the product under study over a period of 10 weeks

Conditions

Interventions

DEVICE

Artificial tear MDI - 101

Medical device CE marked - artificial tears containing arabinogalactan, trehalose and hyaluronic acid - 10 weeks treatment

Sponsors & Collaborators

  • Hippocrates Research

    collaborator OTHER

  • Nubilaria Srl

    collaborator UNKNOWN

  • MD Italy

    lead INDUSTRY

Principal Investigators

  • Ophthalmology unit · Lucca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Italy

Study Locations

More Related Trials

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 NCT04633863 on ClinicalTrials.gov