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

NCT06921525 | Not Yet Recruiting Phase 1

• 5 other identifiers: TTO vs Azithromycine in MGDRewan Hassan Hamid MohamoudDalia Refat El-AfifyTamer Ibrahim AbdelhalimFedaa Abd Elmonem Kotkata
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Change in IL-8 and IL-17 levels .

  after 4 weeks of treatment

Secondary Outcomes (5)

• Change in clinical parameters (TBUT, OSDI, DEQS, Schirmer test).

  after 4 weeks of treatment

• Change in meibomian gland function grading (from 0 to 4)

  after 4 weeks of treatment

• Change in parameter OSDI (ocular surface disease index) from 0 to 100 points.

  after 4 weeks of treatment

• Change in the parameter DEQS (Dry Eye-Related Quality-of-Life Score) from 0 to 100 points.

  after 4 weeks of treatment

• Change in the parameter Schirmer test (from 0 to 15 mm).

  after 4 weeks of treatment

Study Arms (2)

Group A (Azithromycin group)

ACTIVE COMPARATOR

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.

Drug: Azithromycin Ophthalmic Solution

Group B (Tea Tree Oil group)

ACTIVE COMPARATOR

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.

Drug: Tea Tree Oil Topical Application Oil

Interventions

Tea Tree Oil Topical Application Oil DRUG

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

Group B (Tea Tree Oil group)

Azithromycin Ophthalmic Solution DRUG

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

Group A (Azithromycin group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ehab Mohamed Elsayed Mohamed Saad: lead
• Tanta University: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: April 10, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04