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

December 1, 2021 updated by: MD Italy

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

DE is a common eye condition that affects 1 to 2 out of 10 persons in the world. Regardless of the underlying ethology, DE is associated with increased inflammation of conjunctiva, cornea and adnexa. As consequence of the recognized role of the inflammation in the etiopathogenesis of DE, direct and indirect anti-inflammatory treatments are currently the cornerstone for the management of DE, leading to the inhibition of the expression of inflammatory mediators on the ocular surface, therefore restoring the secretion of a healthy tear film and consequently reducing signs and symptoms of DE.

MDI - 101, the product under study containing arabinogalactan (AG), trehalose and hyaluronic acid (HA) ,is a medical device with European Conformity (CE) mark that, thanks to the muco-adhesive proprieties of AG enriches the natural mucous of the tear film providing enhanced lubrication and protection and anti-inflammatory properties, in combination with trehalose and HA. The aim of this study is to demonstrate that the reduced ocular discomfort and the improvement of the integrity of the ocular surface are due to the interruption of the "vicious cycle of inflammation".

This open-label study involves a cohort of 24 patients with clinical and instrumental signs of inflammation of the ocular surface and includes end-points of efficacy, safety and evaluation of inflammation markers. The study includes 6 visits over 10 weeks, 8 of which of active treatment. This study is conducted during the Covid-19 pandemic and for this reason, clinical assessments of all the 24 patients are carried out remotely, from patients' home, with the adoption of digital solutions that determine: reduction of 66% of physical contacts between investigator and patient, a total of 90% of efficacy and safety data collected remotely and a reduction of 100% of physical contacts between investigator and clinical monitor, keeping the study entirely within the Good Clinical Practice framework.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Lucca, Italy
        • Ophthalmology unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subjects who gave their written consent for participation in the study and for personal data processing and willing to comply with all study procedures.
  2. Males or females 30-75 years old.
  3. Subjects who are familiar with the needs of the study in the use of mobile devices and internet.
  4. Subjects who successfully completed the electronic registration for the clinical trial using their own study electronic Patient Reported Outcome (ePRO) profile and completed the OSDI questionnaire.

  5. Subjects who had been diagnosed as having dry eye symptoms for at least 3 months, fulfilling all the following four criteria:

    i. OSDI score of >18 evaluated by the questionnaire of Ocular Surface Disease Index (OSDI); ii. Non-invasive breakup time (NIBUT) ≤10 seconds at least in one eye; iii. Levels of MMP-9 in tears ≥ 40 ng/ml as assessed by the Inflammatory assay at least in one eye; iv. Cornea surface scores ≥1 and <4, based on Efron grading system. -

Exclusion Criteria:

  1. Contact lens wearers.
  2. Subjects who did use any artificial tear for at least 7 days before baseline.
  3. Severe corneal damage (cornea surface scores ≥4, based on Efron grading system) or cornea surface normal (scores <1 based on Efron grading system)
  4. Corneal abrasions or other corneal abnormalities, blepharitis, meibomitis, lid abnormalities.
  5. Conjunctivitis of infective or allergic origins, ongoing or resolved less than 4 weeks before baseline visit.
  6. Subjects participating in another clinical study, on-going or completed less than 4 weeks before.
  7. Subject using, or will use during the study, other artificial tear or other ophthalmic products including, but not limited, to: corticosteroids, antibiotics, vasoconstrictor agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MDI - 101
Artificial tear containing arabinogalactan, trehalose and hyaluronic acid
Device: Artificial tear MDI - 101
Medical device CE marked - artificial tears containing arabinogalactan, trehalose and hyaluronic acid - 10 weeks treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Ocular Surface Disease Index (OSDI)
Time Frame: 1 week - 2 weeks - 4 weeks - 6 weeks - 8 weeks
Change of OSDI score versus baseline at any study time-point. The main goal of the study is to gather information about the efficacy, assessed by OSDI (Ocular Surface Disease Index) questionnaire, of artificial tear containing AG, trehalose and HA (MDI - 101) used in the treatment of symptoms of DE of various aetiology, with evidence of inflammation of the ocular surface. The OSDI score ranges from 0 (better outcome) to 100 (worst outcome)
1 week - 2 weeks - 4 weeks - 6 weeks - 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional efficacy parameters: Matrix Metalloproteinase 9 (MMP-9)
Time Frame: 8 weeks
Change of tear matrix metalloproteinase(MMP)-9 at T0 vs final assessment. The result of the MMP test could be NEGATIVE if the level of MMP-9 is < 40 ng/ml (better outcome) or POSITIVE if the level of MMP-9 is ≥ 40 ng/ml (worst outcome)
8 weeks
Additional Efficacy parameters: EFRON SCALE
Time Frame: 8 weeks
Change of Efron Grading Scales at T0 vs final assessment. The Efron grading scale range from 0 (cornea surface normale) to 4 (severe corneal damage)
8 weeks
Additional Efficacy parameters: Corneal and Conjunctival Staining
Time Frame: 8 weeks
Change of Corneal and Conjunctival Staining at T0 vs final assessment. The Staining scale ranges from 0 (better outcome) to 3 (worst outcome)
8 weeks
Additional Efficacy parameters: NIBUT
Time Frame: 8 weeks
Change of NIBUT at T0 vs final assessment. The result of the Non-Invasive Break-Up Time (NIBUT) test could be >10 seconds (better outcome) or ≤10 seconds (worst outcome)
8 weeks
Additional Efficacy parameters: Osmolarity
Time Frame: 8 weeks
Change of Osmolarity at T0 vs final assessment. The higher the tear film osmolarity, the greater the severity of the ocular surface damage.
8 weeks
Additional Efficacy parameters: Ocular Protection Index
Time Frame: 8 weeks
Change of Ocular Protection Index (OPI) at T0 vs final assessment The principle of the test is that when BUT is shorter than the blink interval, the eyes are exposed to the risk of focal ocular surface damage.
8 weeks
Additional Efficacy parameters: meniscometry
Time Frame: 8 weeks
Change of meniscometry at T0 vs final assessment. The lowest tear meniscus radius, the higher the severity of the ocular surface health
8 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 8 weeks
Safety Adverse Event (AE) experienced with the artificial tear assessed by the patient, before the ocular examination or reported by the patient at any time during the study.
8 weeks
Incidence of change in the unaided and corrected visual acuity
Time Frame: 8 weeks
Unaided and corrected visual acuity Snellen test will be performed to evaluate change in the unaided and corrected visual acuity at T0 vs final assessment.
8 weeks
Incidence of change in the Intraocular pressure
Time Frame: 8 weeks
Change of Intraocular pressure at T0 vs final assessment.
8 weeks
Evaluation of the Tolerability Signs and symptoms of discomfort
Time Frame: 8 weeks
Treatment adherence assessed by the patient at any study time-point (number of instillations in the past 24 hours).
8 weeks
Treatment adherence (24 hours)
Time Frame: 8 weeks
Treatment adherence assessed by the patient at any study time-point (number of instillations in the past 24 hours)
8 weeks
Treatment adherence (total days)
Time Frame: 8 weeks
Treatment adherence assessed by the patient at any study time-point (number of days of product usage).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MD Italy

Collaborators

Hippocrates Research
Nubilaria Srl

Investigators

  • Principal Investigator: Ophthalmology unit, Lucca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2020

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 11, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

December 1, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDI - 101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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