Dry EyeNCT07453212
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
A study testing Dietary Supplement: Microbiome-targeted oral supplement in people with Dry Eye and Evaporative Dry Eye Disease, run by Varol TUNALI at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye, Evaporative Dry Eye Disease, Meibomian Gland Dysfunction (Disorder)
- What is being tested?
- Dietary Supplement: Microbiome-targeted oral supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
- Pregnancy or breastfeeding (if applicable) or planning pregnancy during the intervention period.
- 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
- Individuals following restrictive or specialized dietary patterns, including ketogenic, vegan, or similar diets
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites
T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, 34384
Istinye University
Istanbul
Medipol University
Istanbul
About this study
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
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.
Read the 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.
- Being tested
- Dietary Supplement: Microbiome-targeted oral supplement, Placebo
- Keywords
- Dry eye, Evaporative dry eye disease, OSDI, TBUT, Schirmer test, Microbiome, Gut-eye axis, Dietary supplement
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement: Microbiome-targeted oral supplementDietary 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).
PlaceboOther
Matched placebo (appearance, taste/odor, packaging) administered once daily for 8 weeks (oral).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8 (end of treatment)
Secondary outcomes (12)
Change from baseline in Ocular Surface Disease Index-6 (OSDI-6) total score (durability)
The Ocular Surface Disease Index-6 (OSDI-6) is a 6-item, patient-reported symptom 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 responses, yielding a total score range of 0 to 24, with higher scores indicating worse symptoms. The outcome is the mean change from baseline in OSDI-6 total score at the Week 16 follow-up visit to assess durability of symptom response after stopping intervention. TFOS DEWS III classifies OSDI-6 scores as 0-3 normal, 4-8 mild-to-moderate, and >8 severe.
Measured: Baseline to Week 16
Change from baseline in Non-Invasive Break-Up Time (NIBUT)
NIBUT (seconds) is a device-based measure of tear film stability obtained without fluorescein dye. The endpoint is mean change from baseline in NIBUT, defined as the average of repeated measurements per protocol (e.g., 2-3 recordings; specify in protocol SOP). Higher values indicate more stable tear film.
Measured: Baseline to Week 8 and Baseline to Week 16
Change from baseline in conjunctival staining score (Oxford grading scheme)
Conjunctival fluorescein staining will be graded using the Oxford grading scheme. Scores range from 0 to 5, with higher scores indicating more severe ocular surface staining (worse ocular surface integrity). The outcome is the mean change from baseline in conjunctival staining score.
Measured: Baseline to Week 8 and Baseline to Week 16
Change from baseline in meibum quality score
Meibomian gland function will be evaluated by standardized digital expression of the lower eyelid meibomian glands. Meibum quality will be graded in eight lower eyelid glands using a 4-point ordinal scale (0-3 per gland), where 0 = clear meibum, 1 = cloudy meibum, 2 = cloudy meibum with particulate debris, and 3 = inspissated/toothpaste-like meibum. A composite meibum quality score will be calculated by summing grades across 8 glands (total score range: 0 to 24). Higher scores indicate worse meibum quality (greater gland secretion abnormality). The outcome is the mean change from baseline in composite meibum quality score at the specified assessment time point(s).
Measured: Baseline to Week 8 and Baseline to Week 16
Change from baseline in meibomian gland dropout score (meibography; SIRIUS)
Non-contact infrared meibography of the upper and lower eyelids will be performed using the SIRIUS device. Meibomian gland dropout will be graded using a pre-specified meiboscore (0 to 3) for each eyelid, where 0 indicates no gland loss and 3 indicates severe gland loss. A total meibography dropout score will be calculated for each eye by summing upper and lower eyelid scores (range 0 to 6), with higher scores indicating worse meibomian gland loss. For each visit, the participant-level value will be the mean of both eyes. The outcome is the mean change from baseline in total meibography dropout score.
Measured: Baseline to Week 8 (end of treatment) and Baseline to Week 16 (8 weeks post-treatment)
Change from baseline in meibomian gland expressibility score
Meibomian gland expressibility will be assessed by standardized digital expression of five central glands of the lower eyelid. Expressibility will be graded using a 4-point ordinal scale (0-3) based on the number of glands yielding liquid secretion: 0 = all five glands expressible; 1 = three to four glands expressible; 2 = one to two glands expressible; and 3 = no glands expressible. The total expressibility score ranges from 0 to 3. Higher scores indicate worse meibomian gland expressibility (greater gland obstruction/dysfunction). The outcome is the mean change from baseline in meibomian gland expressibility score
Measured: Baseline to Week 8 and Baseline to Week 16
Conjunctival redness severity (Efron grading scale)
Change from baseline in conjunctival redness severity graded using the Efron Grading Scale for bulbar conjunctival hyperemia. The Efron scale ranges from 0 to 4 (including half grades, if used per protocol), with higher scores indicating greater conjunctival redness (worse hyperemia). The outcome is the mean change from baseline in conjunctival redness score.
Measured: Baseline (Week 0), Week 8 (End of Treatment), and Week 16 (Follow-up)
Change from baseline in Schirmer I test without anesthesia (mm/5 min)
Schirmer I test without topical anesthesia measures aqueous tear production using standardized paper strips placed in the lower fornix for 5 minutes. Results are recorded in millimeters of wetting (mm/5 min). The outcome is the mean change from baseline in Schirmer I test value. Higher values indicate greater tear production (improved tear secretion).
Measured: Baseline (Week 0), Week 8 (End of Treatment), and Week 16 (Follow-up)
Change from baseline in rescue artificial tear use (drops/day)
Average number of rescue artificial tear instillations per day recorded by diary or structured recall over a defined window prior to each visit. Lower values indicate reduced need for rescue therapy.
Measured: Baseline to Week 8 (end of treatment) and Baseline to Week 16 (8 weeks post-treatment)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants experiencing any AE/SAE; severity and relatedness assessed by investigator.
Measured: Baseline through Week 16 (8 weeks post-treatment)
Change in gut microbiome alpha diversity (e.g., Shannon index)
Alpha diversity computed from 16S rRNA sequencing data; change from baseline.
Measured: Baseline to Week 8
Change in gut microbiome beta diversity (Bray-Curtis distance)
Community structure shift tested via PERMANOVA; within-subject distances summarized.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varol TUNALI
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization, Istanbul Medipol University Hospital, İstinye University
- Responsible party
- Sponsor-investigator, Varol TUNALI, ENBIOSIS BIOTECHNOLOGIES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453212
- Sponsor's protocol ID
- 10840098-202.3.02-444
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in the final publication, including demographic variables, baseline characteristics, outcome measures (e.g., OSDI, NIBUT/TBUT, staining scores, Schirmer, meibography parameters), adverse events, and adherence variables.