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Jämförande effektivitet av tea träd olja kontra topisk azitromycin vid behandling av torrt öga

28 september 2026 uppdaterad av: Ehab Mohamed Elsayed Mohamed Saad

Jämförelse av effekten av tea träd olja kontra topisk azitromycin vid behandling av torr ögonsjukdom förknippad med meibomian körteldysfunktion: ett fokus på tårinterleukin nivå

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.

Studieöversikt

Detaljerad beskrivning

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 .

Studietyp

Interventionell

Inskrivning (Faktisk)

50

Fas

  • Fas 2
  • Fas 1

Kontakter och platser

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Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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

Aktiv komparator: 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,

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Förändring i IL-8 och IL-17-nivåer.
Tidsram: Efter 4 veckors behandling
Efter 4 veckors behandling

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Förändring i Meibomian körtelfunktion (från 0 till 4)
Tidsram: Efter 4 veckors behandling
Efter 4 veckors behandling
Change in clinical parameters (TBUT, OSDI, DEQS, Schirmer test).
Tidsram: 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.
Tidsram: 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.
Tidsram: 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).
Tidsram: 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

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Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 mars 2025

Primärt slutförande (Faktisk)

1 oktober 2025

Avslutad studie (Faktisk)

1 oktober 2025

Studieregistreringsdatum

Först inskickad

23 mars 2025

Först inskickad som uppfyllde QC-kriterierna

9 april 2025

Första postat (Faktisk)

10 april 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Läkemedels- och apparatinformation, studiedokument

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