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ENROLLING BY INVITATION
NCT07453212
NA

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

Sponsor: Varol TUNALI

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Evaluating the Efficacy and Safety of a Microbiome-Focused Oral Food Supplement in Adults With Moderate Evaporative Dry Eye Disease Associated With Meibomian Gland Dysfunction

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2026-03-01

Completion Date

2026-11-30

Last Updated

2026-03-09

Healthy Volunteers

No

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).

Locations (3)

T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi

Istanbul, Turkey (Türkiye)

Istinye University

Istanbul, Turkey (Türkiye)

Medipol University

Istanbul, Turkey (Türkiye)