Study on Safety and Performance of an Artificial Tear in Dry Eye Treatment in Subjects With Ocular Surface Inflammation
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Inflammation
Study type: Interventional

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
    

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.
    

Intervention name(s): Artificial tear MDI - 101
Intervention type(s): Device
Intervention description(s): Medical device CE marked - artificial tears containing arabinogalactan, trehalose and hyaluronic acid - 10 weeks treatment
Intervention MeSH terms: Lubricant Eye Drops
Intervention model: Single Group Assignment
Intervention model description: Open label study
Masking: None (Open Label)
Primary purpose: Treatment