Could a daily supplement soothe dry eyes?
NCT ID NCT07453212
First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times
Summary
This study tests whether an oral supplement that targets gut bacteria can improve dry eye symptoms in adults with moderate evaporative dry eye disease. Over 8 weeks, 130 participants will take either the supplement or a placebo. The main goal is to see if symptoms, measured by a standard questionnaire, improve more with the supplement.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- microbiome-targeted oral food supplement
- What this could lead to
- If it works, this could offer a simple, non-invasive way to ease dry eye symptoms by targeting gut health.
- What could go wrong
- This is an early-stage trial with only 130 participants, so results may not apply to everyone. The supplement may not work better than a placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2026
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Dry eye are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Istinye University
Istanbul, Turkey (Türkiye)
-
Medipol University
Istanbul, Turkey (Türkiye)
-
T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
Istanbul, 34384, Turkey (Türkiye)
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a 13-Minute eye exercise routine ease screen strain?
- Gel plug in tear duct tested to keep eyes moist after cataract surgery
- A gel plug for tear ducts may stop post-surgery dry eye
- Can a thymosin beta 4 eye drop soothe dry eye?
- Insulin-spiked eye drops may ease stubborn dry eye in Sjögren's patients
- Can four eye scanners detect how miebo stabilizes tears?