Clinical trial NCT04633863: Study on Safety and Performance of an Artificial Tear in Dry Eye Treatment in Subjects With Ocular Surface Inflammation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: MD Italy
Sponsor class: INDUSTRY
Collaborators: name: Hippocrates Research
name: Nubilaria Srl
First posted: 2020-11-18
Enrollment: 24
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label study
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy - Ocular Surface Disease Index (OSDI)
timeFrame: 1 week - 2 weeks - 4 weeks - 6 weeks - 8 weeks
Secondary outcomes:
measure: Additional efficacy parameters: Matrix Metalloproteinase 9 (MMP-9)
timeFrame: 8 weeks
measure: Additional Efficacy parameters: EFRON SCALE
timeFrame: 8 weeks
measure: Additional Efficacy parameters: Corneal and Conjunctival Staining
timeFrame: 8 weeks
measure: Additional Efficacy parameters: NIBUT
timeFrame: 8 weeks
measure: Additional Efficacy parameters: Osmolarity
timeFrame: 8 weeks
measure: Additional Efficacy parameters: Ocular Protection Index
timeFrame: 8 weeks
measure: Additional Efficacy parameters: meniscometry
timeFrame: 8 weeks
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 8 weeks
measure: Incidence of change in the unaided and corrected visual acuity
timeFrame: 8 weeks
measure: Incidence of change in the Intraocular pressure
timeFrame: 8 weeks
measure: Evaluation of the Tolerability Signs and symptoms of discomfort
timeFrame: 8 weeks
measure: Treatment adherence (24 hours)
timeFrame: 8 weeks
measure: Treatment adherence (total days)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lucca
country: Italy
facility: Ophthalmology unit
Study officials:
affiliation: Lucca
name: Ophthalmology unit
role: PRINCIPAL_INVESTIGATOR
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