Comparing Efficacy of Tea Tree Oil Versus Topical Azithromycin in Treating Dry Eye

NCT ID: NCT06921525

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-08-01

Brief Summary

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 .

Conditions

Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Azithromycin Ophthalmic Solution

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Tea Tree Oil Topical Application Oil

Intervention Type: DRUG

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

Interventions

Tea Tree Oil Topical Application Oil

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

Intervention Type: DRUG

Azithromycin Ophthalmic Solution

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Ehab Mohamed Elsayed Mohamed Saad

OTHER

Sponsor Role: lead

Responsible Party

Ehab Mohamed Elsayed Mohamed Saad

Lecturer

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

Rewan Hassan Hamid Mohamoud

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Dalia Refat El-Afify

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Tamer Ibrahim Abdelhalim

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Fedaa Abd Elmonem Kotkata

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TTO vs Azithromycine in MGD

Identifier Type: -

Identifier Source: org_study_id