CompletedNot Applicable

Effect of a Dietary Supplement on Gut Microbiota and Ocular Surface Outcomes in Dry Eye Disease

Turkey (Türkiye)20 participantsStarted 2025-10-01

Plain-language summary

This prospective clinical study investigates whether a dietary supplement product can modulate the gut microbiota and improve ocular surface outcomes in patients with dry eye disease. Participants will be recruited from Istanbul Medipol University Hospital (Department of Ophthalmology) and Liv Hospitals (Vadi Istanbul and Ulus). Each participant will receive the dietary supplement product for 8 weeks. Gut microbiota analyses will be conducted at baseline and week 8. Ocular surface assessments including Schirmer test and invasive tear breakup time (TBUT) will be performed at baseline and week 8.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Adults aged 18-65 years. Clinical diagnosis of dry eye disease with clinically significant symptoms, defined as Ocular Surface Disease Index (OSDI) score ≥23 at screening and/or baseline. Evidence of tear film instability consistent with dry eye disease, defined as fluorescein tear break-up time (TBUT) ≤10 seconds in at least one eye at screening and/or baseline. Willing and able to provide written informed consent. Willing to maintain habitual diet and lifestyle during the study period and to avoid initiating new microbiome-active products (e.g., probiotic/prebiotic/synbiotic supplements) during the intervention. Exclusion Criteria: Current restrictive dietary pattern likely to materially alter gut microbiota (e.g., ketogenic diet, elimination diets, prolonged fasting) or planned major dietary change during the study period. Colonoscopy within the past 4 weeks. Systemic antibiotic use within the past 4 weeks. Use of probiotic, prebiotic, synbiotic, postbiotic, or fecal microbiota-related products within the past 4 weeks. Active ocular infection or acute ocular inflammation requiring treatment escalation (e.g., acute blepharitis flare, active allergic conjunctivitis requiring escalation), at screening/baseline. Sjögren syndrome or other active systemic autoimmune disease with clinically significant ocular involvement, in the investigator's judgment. Ocular surgery (including refractive surgery) or significant ocular trauma within the past 6 mo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial looked at a dietary supplement's effect on gut microbiota and dry eye — can you explain how changes in gut bacteria might actually influence my tear production or meibomian gland function, and whether that connection is well-established enough to guide my treatment?
2The primary thing they measured was the Schirmer test score, which tracks how much tears are produced — do you know if the results showed a meaningful improvement in that score, and how would that compare to the tear production changes we'd expect from my current or planned treatments?
3Since this trial is already completed, would you be able to access or look up the published results, and do you think the findings are strong enough to consider adding a similar dietary supplement to my care plan?
4This study focused on both dry eye disease and meibomian gland dysfunction — given my specific diagnosis, do you think my condition more closely matches the population studied in this trial, and does that affect how relevant the results might be for me?
5Because this was a 'Phase NA' study involving a dietary supplement rather than a drug, what does that mean for how confident we can be about its safety and effectiveness compared to standard dry eye treatments I might already be a candidate for?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Schirmer Test Score

Timeframe: Baseline to Week 8 (Treatment End) and Baseline to Week 16 (Follow-up)

Trial details

NCT IDNCT07148271

SponsorVarol TUNALI

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-20

View on ClinicalTrials.gov More Dry Eye trials