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Dry Eye DiseaseNCT04633863

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

A study testing Artificial tear MDI - 101 in people with Dry Eye Disease, run by MD Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Dry Eye Disease
What is being tested?
Artificial tear MDI - 101
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteItaly
Study dates
12 Oct 2020to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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. -

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Ophthalmology unit

    Lucca

Other trials in Italy

About this study

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

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

Read the 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.

Conditions
Dry Eye Disease
Being tested
Artificial tear MDI - 101
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial tear MDI - 101Device

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

Study groups in NCT04633863
Study groupRoleWhat they receive
MDI - 101ExperimentalArtificial tear containing arabinogalactan, trehalose and hyaluronic acid
Receives: Device: Artificial tear MDI - 101

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 1 week - 2 weeks - 4 weeks - 6 weeks - 8 weeks

Secondary outcomes (13)

  1. Additional efficacy parameters: Matrix Metalloproteinase 9 (MMP-9)

    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)

    Measured: 8 weeks

  2. Additional Efficacy parameters: EFRON SCALE

    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)

    Measured: 8 weeks

  3. Additional Efficacy parameters: Corneal and Conjunctival Staining

    Change of Corneal and Conjunctival Staining at T0 vs final assessment. The Staining scale ranges from 0 (better outcome) to 3 (worst outcome)

    Measured: 8 weeks

  4. Additional Efficacy parameters: NIBUT

    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)

    Measured: 8 weeks

  5. Additional Efficacy parameters: Osmolarity

    Change of Osmolarity at T0 vs final assessment. The higher the tear film osmolarity, the greater the severity of the ocular surface damage.

    Measured: 8 weeks

  6. Additional Efficacy parameters: Ocular Protection Index

    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.

    Measured: 8 weeks

  7. Additional Efficacy parameters: meniscometry

    Change of meniscometry at T0 vs final assessment. The lowest tear meniscus radius, the higher the severity of the ocular surface health

    Measured: 8 weeks

  8. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    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.

    Measured: 8 weeks

  9. Incidence of change in the unaided and corrected visual acuity

    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.

    Measured: 8 weeks

  10. Incidence of change in the Intraocular pressure

    Change of Intraocular pressure at T0 vs final assessment.

    Measured: 8 weeks

  11. Evaluation of the Tolerability Signs and symptoms of discomfort

    Treatment adherence assessed by the patient at any study time-point (number of instillations in the past 24 hours).

    Measured: 8 weeks

  12. Treatment adherence (24 hours)

    Treatment adherence assessed by the patient at any study time-point (number of instillations in the past 24 hours)

    Measured: 8 weeks

  13. Treatment adherence (total days)

    Treatment adherence assessed by the patient at any study time-point (number of days of product usage).

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start12 Oct 2020
  3. Primary completion30 Nov 2021
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label study
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04633863
Sponsor's protocol ID
MDI - 101
Status last verified
Dec 2021
First submitted
6 Nov 2020
Last updated
2 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Battelli MG, Bolognesi A, Polito L. Pathophysiology of circulating xanthine oxidoreductase: new emerging roles for a multi-tasking enzyme. Biochim Biophys Acta. 2014 Sep;1842(9):1502-17. doi: 10.1016/j.bbadis.2014.05.022. Epub 2014 May 29.

    PubMed 24882753

  • Baudouin C. [A new approach for better comprehension of diseases of the ocular surface]. J Fr Ophtalmol. 2007 Mar;30(3):239-46. doi: 10.1016/s0181-5512(07)89584-2. French.

    PubMed 17417148

  • Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.

    PubMed 28736340

  • Burgalassi S, Nicosia N, Monti D, Falcone G, Boldrini E, Chetoni P. Larch arabinogalactan for dry eye protection and treatment of corneal lesions: investigations in rabbits. J Ocul Pharmacol Ther. 2007 Dec;23(6):541-50. doi: 10.1089/jop.2007.0048.

    PubMed 18001233

  • Cejka C, Kubinova S, Cejkova J. Trehalose in ophthalmology. Histol Histopathol. 2019 Jun;34(6):611-618. doi: 10.14670/HH-18-082. Epub 2019 Jan 9.

    PubMed 30623968

  • Choy CK, Cho P, Boost MV. Cytotoxicity of rigid gas-permeable lens care solutions. Clin Exp Optom. 2013 Sep;96(5):467-71. doi: 10.1111/cxo.12039. Epub 2013 May 3.

    PubMed 23638722

  • Efron N, Morgan PB, Jagpal R. Validation of computer morphs for grading contact lens complications. Ophthalmic Physiol Opt. 2002 Jul;22(4):341-9. doi: 10.1046/j.1475-1313.2002.00049.x.

    PubMed 12162486

  • Kelly GS. Larch arabinogalactan: clinical relevance of a novel immune-enhancing polysaccharide. Altern Med Rev. 1999 Apr;4(2):96-103.

    PubMed 10231609

  • Hessen M, Akpek EK. Dry eye: an inflammatory ocular disease. J Ophthalmic Vis Res. 2014 Apr;9(2):240-50.

    PubMed 25279127

  • 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.

    PubMed 10487426

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

    PubMed 19177348

  • Li W, Sun X, Wang Z, Zhang Y. A survey of contact lens-related complications in a tertiary hospital in China. Cont Lens Anterior Eye. 2018 Apr;41(2):201-204. doi: 10.1016/j.clae.2017.10.007. Epub 2017 Oct 21.

    PubMed 29033270

  • Pahuja P, Arora S, Pawar P. Ocular drug delivery system: a reference to natural polymers. Expert Opin Drug Deliv. 2012 Jul;9(7):837-61. doi: 10.1517/17425247.2012.690733. Epub 2012 Jun 16.

    PubMed 22703523

  • Shi YH, Zhou LT, Zhang CX, Li YZ, Zhang JZ, Zhou HM, Li YG, Liu T, Zhang LL, Sun LN, Chen Z. Effects of carbomer eye drops in combination with orthokeratology lens in treating adolescent myopia. J Biol Regul Homeost Agents. 2016 Oct-Dec;30(4):1029-1033.

    PubMed 28078849

  • Silvani L, Bedei A, De Grazia G, Remiddi S. Arabinogalactan and hyaluronic acid in ophthalmic solution: Experimental effect on xanthine oxidoreductase complex as key player in ocular inflammation (in vitro study). Exp Eye Res. 2020 Jul;196:108058. doi: 10.1016/j.exer.2020.108058. Epub 2020 May 4.

    PubMed 32380019

Questions about this trial

What is this clinical trial studying?

A study testing Artificial tear MDI - 101 in people with Dry Eye Disease, run by MD Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy - Ocular Surface Disease Index (OSDI) (time frame: 1 week - 2 weeks - 4 weeks - 6 weeks - 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04633863, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.

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