Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction
NCT ID: NCT06800274
Last Updated: 2025-07-15
Study Results
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Basic Information
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COMPLETED
PHASE4
134 participants
INTERVENTIONAL
2023-04-21
2024-03-28
Brief Summary
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Detailed Description
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In previous studies, NAAGA has demonstrated efficacy in reducing ocular surface inflammation, improving tear film stability, and alleviating symptoms of dry eye disease (DED). It has been reported a significant reduction in inflammatory markers, such as HLA-DR expression, and improvement in tear break-up time (TBUT) and Ocular Surface Disease Index (OSDI) scores in patients treated with NAAGA. Another investigation comparing NAAGA to cyclosporine A noted faster symptom relief and fewer adverse effects with NAAGA, highlighting its tolerability and potential for broader application. However, the literature lacks robust, head-to-head comparisons of NAAGA with second-generation antihistamines, such as azelastine, in the context of allergic conjunctivitis with tear film dysfunction.
Based on this background, this randomized, single-blind trial is designed to compare the efficacy and safety of NAAGA (49 mg/mL) with azelastine hydrochloride (0.05%) in treating patients with mild-to-moderate allergic conjunctivitis associated with tear film dysfunction. Both treatments target key mechanisms of disease but differ in their primary mode of action. NAAGA offers dual anti-inflammatory and mast cell-stabilizing effects, while azelastine acts predominantly as an H1 receptor antagonist with additional mast cell stabilization.
The primary objective of this study is to demonstrate that NAAGA is non-inferior to azelastine in improving symptoms and clinical parameters of allergic conjunctivitis associated with tear film dysfunction. Specifically, the study will evaluate changes in the Ocular Surface Disease Index (OSDI) score over four weeks of treatment. Secondary objectives include assessing changes in tear osmolarity, TBUT, Schirmer test results, MMP-9 levels, and corneal staining scores, as well as patient-reported symptoms of ocular discomfort.
This trial will include 134 patients with atopy and mild-to-moderate tear film dysfunction, randomized to receive either NAAGA eye drops (administered four times daily) or azelastine eye drops (administered twice daily) for four weeks. Both groups will undergo comprehensive evaluations, including the OSDI questionnaire, tear osmolarity testing, Schirmer I test, TBUT measurement, MMP-9 assessment, and fluorescein staining of the ocular surface. Patient-reported discomfort will be tracked through weekly diaries.
The investigation is expected to provide critical insights into the comparative efficacy and safety of NAAGA and azelastine in this patient population. NAAGA's dual-action profile may offer broader therapeutic benefits, particularly in addressing inflammation-driven tear film instability and ocular surface damage. Results from this study could inform clinical decision-making and support the development of more targeted, personalized treatments for patients with allergic conjunctivitis and tear film dysfunction.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NAAGA Group
NAAGA (N-acetyl-aspartyl-glutamate) 49 mg/mL
80 patients were randomly assigned to NAAGA in single dose (49 mg/mL), instilled as 1 drop per eye four times daily for four weeks. Specific diagnostic tests and procedures for dry eye disease were performed at week 0 (baseline), week 2 and week 4.
Azelastine Group
azelastine hydrochloride 0.05%
54 patients were randomly assigned to azelastine hydrochloride 0.05% instilled as 1 drop per eye 2 times a day in the conjunctival sac for for four weeks. Specific diagnostic tests and procedures for dry eye disease were performed at week 0 (baseline), week 2 and week 4.
Interventions
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NAAGA (N-acetyl-aspartyl-glutamate) 49 mg/mL
80 patients were randomly assigned to NAAGA in single dose (49 mg/mL), instilled as 1 drop per eye four times daily for four weeks. Specific diagnostic tests and procedures for dry eye disease were performed at week 0 (baseline), week 2 and week 4.
azelastine hydrochloride 0.05%
54 patients were randomly assigned to azelastine hydrochloride 0.05% instilled as 1 drop per eye 2 times a day in the conjunctival sac for for four weeks. Specific diagnostic tests and procedures for dry eye disease were performed at week 0 (baseline), week 2 and week 4.
Eligibility Criteria
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Inclusion Criteria
* Mild-to-moderate tear film dysfunction defined by OSDI scores ≥13 and at least one diagnostic abnormality (TBUT \<10 sec, Schirmer I test \<10 mm, CLEK score for corneal staining \>1, or tear osmolarity \>308 mOsm/L).
Exclusion Criteria
* Unilateral dry eye syndrome.
* Recent ocular surgery (within 3 months) or refractive surgery (within 6 months).
. - Active ocular infections.
* Previous herpetic keratitis.
* Systemic or topic therapies with steroids in the last three months.
* Local therapies in the last 14 days.
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
OTHER
Responsible Party
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Mario Troisi
MD
Principal Investigators
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Mario Troisi, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy
Locations
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Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, Salerno, Italy
Countries
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References
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Suarez-Cortes T, Merino-Inda N, Benitez-Del-Castillo JM. Tear and ocular surface disease biomarkers: A diagnostic and clinical perspective for ocular allergies and dry eye disease. Exp Eye Res. 2022 Aug;221:109121. doi: 10.1016/j.exer.2022.109121. Epub 2022 May 21.
Shin D, Sang Min J. Comparison of treatment effects between 4.9% N-acetyl-aspartyl glutamic acid and 0.05% cyclosporine A eye drops in dry eye patients. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3285-3291. doi: 10.1007/s00417-022-05682-x. Epub 2022 Apr 29.
Regu VR, Swain RP, Subudhi BB. Drug Delivery for Ocular Allergy: Current Formulation Design Strategies and Future Perspectives. Curr Pharm Des. 2023;29(33):2626-2639. doi: 10.2174/0113816128275375231030115828.
Leonardi A, Quintieri L, Presa IJ, LLoves JM, Montero J, Benitez-Del-Castillo JM, Leston FJS, Gonzalez-Mancebo E, Asero R, Groblewska A, Kuna P. Allergic Conjunctivitis Management: Update on Ophthalmic Solutions. Curr Allergy Asthma Rep. 2024 Jul;24(7):347-360. doi: 10.1007/s11882-024-01150-0. Epub 2024 Jun 13.
Kumar N, Feuer W, Lanza NL, Galor A. Seasonal Variation in Dry Eye. Ophthalmology. 2015 Aug;122(8):1727-9. doi: 10.1016/j.ophtha.2015.02.013. Epub 2015 Apr 6. No abstract available.
Janeczko P, Norris MR, Bielory L. Assessment of receptor affinities of ophthalmic and systemic agents in dry eye disease. Curr Opin Allergy Clin Immunol. 2021 Oct 1;21(5):480-485. doi: 10.1097/ACI.0000000000000773.
James IG, Campbell LM, Harrison JM, Fell PJ, Ellers-Lenz B, Petzold U. Comparison of the efficacy and tolerability of topically administered azelastine, sodium cromoglycate and placebo in the treatment of seasonal allergic conjunctivitis and rhino-conjunctivitis. Curr Med Res Opin. 2003;19(4):313-20. doi: 10.1185/030079903125001785.
Jambou D, Lapalus P. Effect of N-acetyl-aspartyl-glutamate (Naaga) on in-vitro leukotriene synthesis by macrophage cell line P388D1. Int J Tissue React. 1990;12(5):273-80.
Herrero-Vanrell R, Jauregui Presa I, Leceta Bilbao A, Montero-Iruzubieta J. Fundamental Aspects and Relevance of Components in Antihistamine Eye Drops. J Investig Allergol Clin Immunol. 2023 Dec;33(6):431-438. doi: 10.18176/jiaci.0963.
Goldschmidt PL, Vulliez-Le Normand B, Briquet I, Dray F. Effects of N-acetyl-aspartyl glutamic acid and sodium cromoglycate on leukotriene B4 secretion by human leukocytes. Allergy. 1990 Jul;45(5):363-9. doi: 10.1111/j.1398-9995.1990.tb00512.x.
Garcia-Queiruga J, Pena-Verdeal H, Sabucedo-Villamarin B, Garcia-Resua C, Giraldez MJ, Yebra-Pimentel E. Temporal Progression of Entry Factors into the Vicious Circle of Dry Eye in Untreated Sufferers. Life (Basel). 2024 Jun 26;14(7):806. doi: 10.3390/life14070806.
Fukuda K, Kishimoto T, Sumi T, Yamashiro K, Ebihara N. Biologics for allergy: therapeutic potential for ocular allergic diseases and adverse effects on the eye. Allergol Int. 2023 Apr;72(2):234-244. doi: 10.1016/j.alit.2022.09.005. Epub 2022 Nov 1.
El Fekih L, Khairallah M, Ben Amor H, Mahmoud A, Chiambaretta F, Messaoud R. Successful management of dry eye disease with a new eye drop formulation combining hyaluronic acid, trehalose, and N-acetyl-aspartyl-glutamic acid (NAAGA). J Fr Ophtalmol. 2024 Sep;47(7):104169. doi: 10.1016/j.jfo.2024.104169. Epub 2024 Jun 4.
Other Identifiers
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ASL Napoli 3 sud n. 31/2019
Identifier Type: -
Identifier Source: org_study_id
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