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

NCT07453212 | Enrolling By Invitation

• 1 other identifier: 10840098-202.3.02-444
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 3

Brief 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)

Keywords

Dry eye; Evaporative dry eye disease; OSDI; TBUT; Schirmer test; Microbiome; Gut-eye axis; Dietary supplement

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Ocular Surface Disease Index-6 (OSDI-6) total score

  The Ocular Surface Disease Index-6 (OSDI-6) is a shortened 6-item patient-reported outcome measure recommended by TFOS DEWS III as the standardized screening questionnaire for dry eye disease. Each item is scored from 0 to 4, and the total score is calculated as the sum of the 6 item scores, yielding a total score range of 0 to 24. Higher scores indicate worse dry eye symptom burden. According to TFOS DEWS III, OSDI-6 scores may be interpreted as follows: 0-3, normal range; 4-8, mild-to-moderate symptom severity; and \>8, severe symptom severity. A score of 4 or higher is considered consistent with a positive symptom screen for dry eye disease. The primary endpoint is the mean change from baseline in OSDI-6 total score at Week 8, corresponding to the end of the intervention period.

  Baseline to Week 8 (end of treatment)

Secondary Outcomes (12)

• Change from baseline in Ocular Surface Disease Index-6 (OSDI-6) total score (durability)

  Baseline to Week 16

• Change from baseline in Non-Invasive Break-Up Time (NIBUT)

  Baseline to Week 8 and Baseline to Week 16

• Change from baseline in conjunctival staining score (Oxford grading scheme)

  Baseline to Week 8 and Baseline to Week 16

• Change from baseline in meibum quality score

  Baseline to Week 8 and Baseline to Week 16

• Change from baseline in meibomian gland dropout score (meibography; SIRIUS)

  Baseline to Week 8 (end of treatment) and Baseline to Week 16 (8 weeks post-treatment)

Study Arms (2)

Microbiome-targeted oral food supplement

EXPERIMENTAL

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). Packaging and appearance are matched to placebo.

Dietary Supplement: Dietary Supplement: Microbiome-targeted oral supplement

Placebo Comparator

PLACEBO COMPARATOR

Participants receive a matched placebo once daily for 8 weeks, plus permitted background dry eye care.

Other: Placebo

Interventions

Placebo OTHER

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

Placebo Comparator

Dietary Supplement: Microbiome-targeted oral supplement DIETARY_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).

Microbiome-targeted oral food supplement

Eligibility Criteria

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

You may not qualify if:

• Sjögren syndrome or other active systemic autoimmune disease with significant ocular involvement (investigator judgment).
• Active ocular infection, acute blepharitis flare, or active allergic conjunctivitis requiring escalation of therapy.
• Ocular surgery (including cataract) or significant ocular trauma within 6 months prior to the Screening Visit.
• Previous LASIK or any prior corneal surgery at any time.
• Use of topical cyclosporine, lifitegrast, or topical ocular corticosteroids within 6-8 weeks prior to baseline, or planned initiation during the treatment period.
• Punctal plugs within 3 months prior to baseline or planned during the study.
• Use of glaucoma medications or history of glaucoma filtering surgery.
• Contact lens use within 30 days prior to baseline or planned use during the study.
• Systemic isotretinoin within 6 months prior to baseline.
• Systemic antibiotic use within 8 weeks prior to baseline.
• Eyelid abnormalities affecting lid function (e.g., lagophthalmos, blepharospasm, ectropion, entropion, severe trichiasis).
• Active thyroid eye disease (thyroid orbitopathy) or clinically significant ocular surface exposure secondary to thyroid dysfunction.
• Extensive ocular surface scarring or conditions compromising ocular surface integrity, including Stevens-Johnson syndrome, prior chemical burn, recurrent corneal erosions, persistent epithelial defects, or prior severe ocular trauma.
• Known hypersensitivity to study product ingredients.
• Any medical or ocular condition that, in the investigator's opinion, would compromise patient safety or study integrity.

Sponsors & Collaborators

• Varol TUNALI: lead
• Istanbul Medipol University Hospital: collaborator
• İstinye University: collaborator
• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: collaborator

Study Sites (3)

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

Istanbul, 34384, Turkey (Türkiye)

Location

Istinye University

Istanbul, Turkey (Türkiye)

Location

Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Supervisor

Study Record Dates

• First Submitted: February 13, 2026
• First Posted: March 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 6 months after publication and ending 5 years after publication.
• Access Criteria: Access will be provided to qualified researchers with a methodologically sound proposal. Requests must include a brief analysis plan and will be reviewed by the study steering committee. Data will be shared under a data use agreement that prohibits re-identification and requires appropriate citation of the original study.

Locations

TU (3)