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Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Condition(s) studied
Dry EyeEvaporative Dry Eye DiseaseMeibomian Gland Dysfunction (Disorder)
Investigational drug(s) / intervention(s)
Dietary Supplement: Microbiome-targeted oral supplementPlacebo
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).
Placebo: Matched placebo (appearance, taste/odor, packaging) administered once daily for 8 weeks (oral).
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.
Eligibility
Incluison criteria:
1. Adults aged 18-65 years.
2. Participants were required to meet all of the following criteria:
* Presence of dry eye symptoms, defined as an OSDI-6 summed score ≥4 at baseline.
* Objective evidence of tear film homeostasis loss in at least one eye, defined by at least one of the following:
A: Non-invasive tear break-up time (NIBUT) \<10 seconds, and/or
B: Ocular surface fluorescein staining consistent with DED, defined as:
* Corneal and/or conjunctival fluorescein staining graded ≥1 using the Oxford scale, and/or
* Lid wiper epitheliopathy graded ≥1 using the Korb grading system
3. Ability to provide written informed consent and comply with study procedures.
4. Willingness to maintain stable use of permitted background measures (e.g., preservative-free artificial tears) and to avoid initiating new probiotics/prebiotics during the trial.
Exclusion criteria:
1. Sjögren syndrome or other active systemic autoimmune disease with significant ocular involvement (investigator judgment).
2. Active ocular infection, acute blepharitis flare, or active allergic conjunctivitis requiring escalation of therapy.
3. Ocular surgery (including cataract) or significant ocular trauma within 6 months prior to the Screening Visit.
4. Previous LASIK or any prior corneal surgery at any time.
5. Use of topical cyclosporine, lifitegrast, or topical ocular corticosteroids within 6-8 weeks prior to baseline, or planned initiation during the treatment period.
6. Punctal plugs within 3 months prior to baseline or planned during the study.
7. Use of glaucoma medications or history of glaucoma filtering surgery.
8. Contact lens use within 30 days prior to baseline or planned use during the study.
9. Systemic isotretinoin within 6 months prior to baseline.
10. Systemic antibiotic use within 8 weeks prior to baseline.
11. Eyelid abnormalities affecting lid function (e.g., lagophthalmos, blepharospasm, ectropion, entropion, severe trichiasis).
12. Active thyroid eye disease (thyroid orbitopathy) or clinically significant ocular surface exposure secondary to thyroid dysfunction.
13. 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.
14. Known hypersensitivity to study product ingredients.
15. Any medical or ocular condition that, in the investigator's opinion, would compromise patient safety or study integrity.
16. Pregnancy or breastfeeding (if applicable) or planning pregnancy during the intervention period.
17. Gastrointestinal diseases known to significantly affect digestion, absorption, or intestinal physiology, including but not limited to inflammatory bowel disease, celiac disease, or a history of major gastrointestinal surgery
18. Individuals following restrictive or specialized dietary patterns, including ketogenic, vegan, or similar diets
Primary outcome measure(s)
- Change from baseline in Ocular Surface Disease Index-6 (OSDI-6) total score — Baseline to Week 8 (end of treatment)
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.
Trial sites (3)
| Facility | City | Region | Status |
| T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi |
Istanbul |
Turkey (Türkiye) |
|
| Istinye University |
Istanbul |
Turkey (Türkiye) |
|
| Medipol University |
Istanbul |
Turkey (Türkiye) |
|
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