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Comparaison de l'efficacité de l'huile d'arbre à thé et de l'azithromycine topique dans le traitement de la sécheresse oculaire

28 septembre 2026 mis à jour par: Ehab Mohamed Elsayed Mohamed Saad

Comparaison de l'efficacité de l'huile d'arbre à thé et de l'azithromycine topique dans le traitement des maladies de la sécheresse oculaire associées au dysfonctionnement des glands de Meibomian: une mise au point sur le niveau de la déchirure de l'interleukine

This study aims to compare the effects of azithromycin and tea tree oil on the clinical outcomes and inflammatory profile of patients with MGD-associated DED. By focusing on changes in tear IL-8 and IL-17 levels, the study seeks to provide insights into the differential mechanisms of these two treatments and their potential in addressing inflammation-driven DED.

Aperçu de l'étude

Description détaillée

Dry eye disease (DED) is a multifactorial condition affecting the ocular surface, characterized by the loss of tear film homeostasis, resulting in discomfort, visual disturbances, and tear film instability . The prevalence of DED is significant, impacting approximately 5%-50% of the global population, with variability influenced by geographic location, age, and environmental factors . The condition not only affects the quality of life but also poses a substantial economic burden due to increased healthcare utilization and reduced productivity .

A hallmark of DED is its complex pathophysiology, which involves a vicious cycle of tear film instability, hyperosmolarity, and chronic inflammation of the ocular surface. Recent advances underscore the critical interplay between these factors and their contribution to symptomatology . Pro-inflammatory cytokines, such as interleukin-8 (IL-8) and interleukin-17 (IL-17), have emerged as key mediators of ocular surface inflammation, amplifying the recruitment of neutrophils and T-helper 17 cells, respectively .

Among the various etiologies of DED, meibomian gland dysfunction (MGD) is recognized as a leading cause. MGD results from abnormalities in the secretion of meibum, a lipid essential for stabilizing the tear film and preventing evaporation . Dysregulation of the lipid layer exacerbates evaporative dry eye and promotes a pro-inflammatory microenvironment, further destabilizing the tear film.

Conventional therapeutic approaches to MGD, such as warm compresses and eyelid hygiene, aim to restore gland function and relieve symptoms. In addition, topical antibiotics, particularly azithromycin, are commonly employed due to their dual antimicrobial and anti-inflammatory properties . Azithromycin has demonstrated efficacy in improving meibomian gland function and reducing inflammation and improving symptoms of dryness of the eye .

Emerging treatments for MGD have focused on addressing the underlying inflammatory and microbial components. Tea tree oil (TTO), derived from the leaves of Melaleuca alternifolia, has garnered attention due to its antimicrobial, anti-inflammatory, and demodicidal properties . TTO has demonstrated efficacy in eradicating Demodex mites, microscopic parasites frequently associated with MGD and DED . Despite these promising effects, its impact on tear cytokine modulation remains an area of active investigation .

Preclinical and clinical studies have begun to elucidate the mechanisms by which TTO exerts its effects. For instance, TTO has been shown to inhibit pro-inflammatory pathways, reduce oxidative stress, and enhance epithelial barrier integrity . These findings suggest a broader therapeutic role for TTO in addressing not only MGD but also other ocular surface diseases characterized by inflammation and microbial dysbiosis .

Despite its potential, challenges remain in the widespread adoption of TTO for MGD. Patient tolerability, particularly regarding ocular irritation, is a critical consideration. Additionally, the lack of large-scale, randomized controlled trials limits the generalizability of existing findings .

In conclusion, while conventional therapies for MGD have been effective, emerging treatments such as TTO offer a promising alternative, particularly in addressing inflammation and microbial factors. Understanding the interplay between TTO, cytokines like IL-8 and IL-17, and the ocular surface could pave the way for novel therapeutic paradigms, ultimately improving outcomes for patients with DED and MGD .

Type d'étude

Interventionnel

Inscription (Réel)

50

Phase

  • Phase 2
  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Benha
      • Banhā, Benha, Egypte, 13111
        • Ebsar Eye Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Tear Break-Up Time (TBUT) ≤10 seconds.
  • Ocular Surface Disease Index (OSDI) score ≥20.
  • Willingness to comply with study requirements and provide informed consent.

Exclusion Criteria:

  • History of ocular surgery or trauma within the past 6 months.
  • Use of systemic or topical anti-inflammatory medications within 4 weeks prior to enrollment.
  • Known hypersensitivity to azithromycin or tea tree oil.
  • Presence of other ocular surface diseases unrelated to MGD.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Group A (Azithromycin group)

Group A (Azithromycin group): 22 patients who will receive topical azithromycin applied twice daily, along with preservative-free lubricant eye drops five times daily for 4 weeks.

Azithromycin has demonstrated efficacy in improving meibomian gland function and reducing inflammation and improving symptoms of dryness of the eye

Comparateur actif: Group B (Tea Tree Oil group)

Group B (Tea Tree Oil group): 22 patients who will receive topical tea tree oil applied twice daily, along with preservative-free lubricant eye drops five times daily for 4 weeks.

Tea tree oil (TTO), derived from the leaves of Melaleuca alternifolia,

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Changement des niveaux d'IL-8 et d'IL-17.
Délai: Après 4 semaines de traitement
Après 4 semaines de traitement

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Changement dans le classement de la fonction des glands de Meibomian (de 0 à 4)
Délai: Après 4 semaines de traitement
Après 4 semaines de traitement
Change in clinical parameters (TBUT, OSDI, DEQS, Schirmer test).
Délai: after 4 weeks of treatment

Change in the parameters TBUT "Tear breakup time'', OSDI ''Ocular Surface Disease Index'', DEQS ''Dry Eye-Related Quality-of-Life Score'' and Schirmer test.

TBUT (from less than 5 to more than 10 seconds). OSDI (from 0 to 100 points) where patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time" a final score is calculated which ranges from 0 to 100 with scores and based on their OSDI scores, patients can be categorized as having a normal ocular surface (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) ocular surface disease.

DEQS (from 0 to 100 points) which is a questionnaire and it was calculated using the following formula: (sum of the degree scores for all questions answered) × 25/(total number of questions answered), with higher scores indicating increased severity of DED symptoms and a greater impact on daily life.

Schirmer test (from 0 to 15 mm).

after 4 weeks of treatment
Change in parameter OSDI (ocular surface disease index) from 0 to 100 points.
Délai: after 4 weeks of treatment

OSDI (from 0 to 100 points) where patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time" a final score is calculated which ranges from 0 to 100 with scores and based on their OSDI scores, patients can be categorized as having a normal ocular surface (0-12 points) or as having mild (13-22 points), moderate (23-32 points), or severe (33-100 points) ocular surface disease.

after 4 weeks of treatment
Change in the parameter DEQS (Dry Eye-Related Quality-of-Life Score) from 0 to 100 points.
Délai: after 4 weeks of treatment

DEQS (from 0 to 100 points) which is a questionnaire and it was calculated using the following formula: (sum of the degree scores for all questions answered) × 25/(total number of questions answered), with higher scores indicating increased severity of DED symptoms and a greater impact on daily life.

after 4 weeks of treatment
Change in the parameter Schirmer test (from 0 to 15 mm).
Délai: after 4 weeks of treatment

Change in the parameter Schirmer test (from 0 to 15 mm) as Schirmer test results are interpreted as follows: 0 to 5 mm: extremely dry eyes. 5 to 10 mm: moderately dry eyes. 10 to 15 mm: possible dry eyes.

after 4 weeks of treatment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2025

Achèvement primaire (Réel)

1 octobre 2025

Achèvement de l'étude (Réel)

1 octobre 2025

Dates d'inscription aux études

Première soumission

23 mars 2025

Première soumission répondant aux critères de contrôle qualité

9 avril 2025

Première publication (Réel)

10 avril 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • TTO vs Azithromycine in MGD
  • Rewan Hassan Hamid Mohamoud (Autre subvention/numéro de financement: Demonstrator of Aharm canadian university)
  • Dalia Refat El-Afify (Autre subvention/numéro de financement: Assistant professor of Clinical pharmacy Faculty of Pharmacy - Tanta University)
  • Tamer Ibrahim Abdelhalim (Autre subvention/numéro de financement: Assistant professor of Ophthalmology Faculty of Medicine -Tanta University)
  • Fedaa Abd Elmonem Kotkata (Autre subvention/numéro de financement: Lecturer of Clinical Pharmacy Faculty of Pharmacy - Tanta University)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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