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

NCT04633863 | Completed

• 1 other identifier: MDI - 101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Efficacy - Ocular Surface Disease Index (OSDI)

  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 Outcomes (13)

• Additional efficacy parameters: Matrix Metalloproteinase 9 (MMP-9)

  8 weeks

• Additional Efficacy parameters: EFRON SCALE

  8 weeks

• Additional Efficacy parameters: Corneal and Conjunctival Staining

  8 weeks

• Additional Efficacy parameters: NIBUT

  8 weeks

• Additional Efficacy parameters: Osmolarity

  8 weeks

Study Arms (1)

MDI - 101

EXPERIMENTAL

Artificial tear containing arabinogalactan, trehalose and hyaluronic acid

Device: Artificial tear MDI - 101

Interventions

Artificial tear MDI - 101 DEVICE

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

MDI - 101

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who gave their written consent for participation in the study and for personal data processing and willing to comply with all study procedures.
• Males or females 30-75 years old.
• Subjects who are familiar with the needs of the study in the use of mobile devices and internet.
• 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.
• 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. -

You may not qualify if:

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

Sponsors & Collaborators

• MD Italy: lead
• Hippocrates Research: collaborator
• Nubilaria Srl: collaborator

Study Sites (1)

Ophthalmology unit

Lucca, Italy

Location

Related Publications (18)

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  PMID: 30623968 RESULT

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• Holden BA, Reddy MK, Sankaridurg PR, Buddi R, Sharma S, Willcox MD, Sweeney DF, Rao GN. Contact lens-induced peripheral ulcers with extended wear of disposable hydrogel lenses: histopathologic observations on the nature and type of corneal infiltrate. Cornea. 1999 Sep;18(5):538-43.

  PMID: 10487426 RESULT

• Jain NK, Roy I. Effect of trehalose on protein structure. Protein Sci. 2009 Jan;18(1):24-36. doi: 10.1002/pro.3.

  PMID: 19177348 RESULT

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MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Ophthalmology unit

  Lucca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 18, 2020
• Study Start: October 12, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)