NCT07453212

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Varol TUNALI · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants with moderate evaporative DED associated with MGD will be randomized 1:1 to receive either a microbiome-focused oral food supplement or matching placebo for 8 weeks. The primary endpoint is change in Ocular Surface Disease Index (OSDI) from baseline to Week 8 and at 16 week follow-up. Key secondary endpoints include changes in tear film breakup time (TBUT), Schirmer I test, and ocular surface staining. Safety and tolerability will be assessed throughout the study. Standard supportive care (e.g., preservative-free artificial tears) will be permitted if kept stable and documented.

Conditions

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-06-30
• Completion: 2026-11-30
• First posted: 2026-03-05
• Last updated: 2026-04-13

Locations

3 sites across 1 country: Turkey (Türkiye)