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Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction

NCT07453212 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-07-28

No results posted yet for this study

Summary

Dry eye disease (DED) is a common chronic condition characterized by ocular surface discomfort and tear film instability. Evaporative DED associated with meibomian gland dysfunction (MGD) is a frequent phenotype and is often driven by inflammatory mechanisms. This randomized, double-blind, placebo-controlled trial evaluates whether an oral microbiome-focused food supplement improves dry eye symptoms and objective clinical signs compared with placebo over 8 weeks in adults with moderate evaporative DED due to MGD.

Conditions

  • Dry Eye
  • Evaporative Dry Eye Disease
  • Meibomian Gland Dysfunction (Disorder)

Interventions

DIETARY_SUPPLEMENT

Dietary Supplement: Microbiome-targeted oral supplement

Oral food-grade supplement designed to modulate gut microbiome-linked metabolic pathways relevant to ocular surface homeostasis (gut-eye axis). Administered once daily for 8 weeks (e.g., sachet/capsule taken with water).

OTHER

Placebo

Matched placebo (appearance, taste/odor, packaging) administered once daily for 8 weeks (oral).

Sponsors & Collaborators

  • Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

    collaborator OTHER

  • Istanbul Medipol University Hospital

    collaborator OTHER

  • İstinye University

    collaborator OTHER

  • Varol TUNALI

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07453212 on ClinicalTrials.gov