Comparing Efficacy of Tea Tree Oil Versus Topical Azithromycin in Treating Dry Eye
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tea Tree Oil Topical Application Oil, Azithromycin Ophthalmic Solution.
- Who it may be relevant to
- Registry conditions: Dry Eye. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Efficacy of Tea Tree Oil Versus Topical Azithromycin in Treating Dry Eye Disease Associated With Meibomian Gland Dysfunction: A Focus on Tear Interleukin Level
Overview
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.
Detailed description
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 .
Interventions
- Drug Tea Tree Oil Topical Application Oil
Tea tree oil (TTO), derived from the leaves of Melaleuca alternifolia, - Drug Azithromycin Ophthalmic Solution
Azithromycin has demonstrated efficacy in improving meibomian gland function and reducing inflammation and improving symptoms of dryness of the eye
Primary outcome measures
- Change in IL-8 and IL-17 levels . [Time frame: after 4 weeks of treatment]
Secondary outcome measures (5)
- Change in clinical parameters (TBUT, OSDI, DEQS, Schirmer test). [Time frame: after 4 weeks of treatment]
- Change in meibomian gland function grading (from 0 to 4) [Time frame: after 4 weeks of treatment]
- Change in parameter OSDI (ocular surface disease index) from 0 to 100 points. [Time frame: after 4 weeks of treatment]
- Change in the parameter DEQS (Dry Eye-Related Quality-of-Life Score) from 0 to 100 points. [Time frame: after 4 weeks of treatment]
- Change in the parameter Schirmer test (from 0 to 15 mm). [Time frame: after 4 weeks of treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06921525 · TTO vs Azithromycine in MGD · Rewan Hassan Hamid Mohamoud · Dalia Refat El-Afify · Tamer Ibrahim Abdelhalim · Fedaa Abd Elmonem Kotkata