NCT06921525

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

March 23, 2025

Last Update Submit

September 28, 2026

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 OilDRUG

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

Group B (Tea Tree Oil group)
Azithromycin Ophthalmic SolutionDRUG

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ebsar Eye Center

Banhā, Benha, 13111, Egypt

Location

Related Publications (1)

  • El-Afify DR, Mahmoud RHH, Kotkata FA, Abdelhalim TI, Saad EME. Evaluating the efficacy of topical tea tree oil versus preservative-free azithromycin in the treatment of dry eye disease associated with meibomian gland dysfunction: A randomized controlled trial focusing on tear interleukin levels. Cont Lens Anterior Eye. 2026 Sep 20;49(6):102843. doi: 10.1016/j.clae.2026.102843. Online ahead of print.

    PMID: 42764009DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye 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

March 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

September 30, 2026

Record last verified: 2026-09

Locations

EG(1)