CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Artificial tear MDI - 101device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04633863
NCT04633863N/ACompleted
CompareCT.gov

Pilot Study on Safety and Performance of an Artificial Tear Containing Arabinogalactan, Trehalose and Hyaluronic Acid in the Treatment of Dry Eye in Subjects With Inflammation of the Ocular Surface

MD Italy·interventional·Posted Nov 18, 2020·Updated Dec 2, 2021

In Brief

A clinical study evaluating Artificial tear MDI - 101 for Dry Eye Disease. Completed, enrolled 24 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesItaly
CollaboratorsHippocrates Research, Nubilaria Srl

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 18, 2020
Enrollment StartOct 12, 2020
Primary CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.6 years ago

Interventions

Artificial tear MDI - 101device

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