Study on Safety and Performance of an Artificial Tear in Dry Eye Treatment in Subjects With Ocular Surface Inflammation
NCT ID: NCT04633863
Last Updated: 2021-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2020-10-12
2021-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MDI - 101
Artificial tear containing arabinogalactan, trehalose and hyaluronic acid
Artificial tear MDI - 101
Medical device CE marked - artificial tears containing arabinogalactan, trehalose and hyaluronic acid - 10 weeks treatment
Interventions
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Artificial tear MDI - 101
Medical device CE marked - artificial tears containing arabinogalactan, trehalose and hyaluronic acid - 10 weeks treatment
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
75 Years
ALL
No
Sponsors
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Hippocrates Research
OTHER
Nubilaria Srl
UNKNOWN
MD Italy
INDUSTRY
Responsible Party
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Principal Investigators
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Ophthalmology unit
Role: PRINCIPAL_INVESTIGATOR
Lucca
Locations
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Ophthalmology unit
Lucca, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Kelly GS. Larch arabinogalactan: clinical relevance of a novel immune-enhancing polysaccharide. Altern Med Rev. 1999 Apr;4(2):96-103.
Hessen M, Akpek EK. Dry eye: an inflammatory ocular disease. J Ophthalmic Vis Res. 2014 Apr;9(2):240-50.
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.
Jain NK, Roy I. Effect of trehalose on protein structure. Protein Sci. 2009 Jan;18(1):24-36. doi: 10.1002/pro.3.
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.
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.
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.
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.
Stuart JC, Linn JG. Dilute sodium hyaluronate (Healon) in the treatment of ocular surface disorders. Ann Ophthalmol. 1985 Mar;17(3):190-2.
Sullivan DA, Rocha EM, Aragona P, Clayton JA, Ding J, Golebiowski B, Hampel U, McDermott AM, Schaumberg DA, Srinivasan S, Versura P, Willcox MDP. TFOS DEWS II Sex, Gender, and Hormones Report. Ocul Surf. 2017 Jul;15(3):284-333. doi: 10.1016/j.jtos.2017.04.001. Epub 2017 Jul 20.
Yokoi N, Komuro A. Non-invasive methods of assessing the tear film. Exp Eye Res. 2004 Mar;78(3):399-407. doi: 10.1016/j.exer.2003.09.020.
Other Identifiers
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MDI - 101
Identifier Type: -
Identifier Source: org_study_id