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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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).
• Другое Placebo
  Matched placebo (appearance, taste/odor, packaging) administered once daily for 8 weeks (oral).

Первичные конечные точки

• Change from baseline in Ocular Surface Disease Index-6 (OSDI-6) total score [Срок оценки: Baseline to Week 8 (end of treatment)]

Вторичные конечные точки (12)

• Change from baseline in Ocular Surface Disease Index-6 (OSDI-6) total score (durability) [Срок оценки: Baseline to Week 16]
• Change from baseline in Non-Invasive Break-Up Time (NIBUT) [Срок оценки: Baseline to Week 8 and Baseline to Week 16]
• Change from baseline in conjunctival staining score (Oxford grading scheme) [Срок оценки: Baseline to Week 8 and Baseline to Week 16]
• Change from baseline in meibum quality score [Срок оценки: Baseline to Week 8 and Baseline to Week 16]
• Change from baseline in meibomian gland dropout score (meibography; SIRIUS) [Срок оценки: Baseline to Week 8 (end of treatment) and Baseline to Week 16 (8 weeks post-treatment)]
• Change from baseline in meibomian gland expressibility score [Срок оценки: Baseline to Week 8 and Baseline to Week 16]
• Conjunctival redness severity (Efron grading scale) [Срок оценки: 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) [Срок оценки: Baseline (Week 0), Week 8 (End of Treatment), and Week 16 (Follow-up)]
• Change from baseline in rescue artificial tear use (drops/day) [Срок оценки: 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) [Срок оценки: Baseline through Week 16 (8 weeks post-treatment)]
• Change in gut microbiome alpha diversity (e.g., Shannon index) [Срок оценки: Baseline to Week 8]
• Change in gut microbiome beta diversity (Bray-Curtis distance) [Срок оценки: Baseline to Week 8]

Критерии участия

Incluison criteria:

• Adults aged 18-65 years.
• 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
• Ability to provide written informed consent and comply with study procedures.
• 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.

Критерии исключения

• 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.
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 3 центра

• T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi — Istanbul
• Istinye University — Istanbul
• Medipol University — Istanbul

Идентификаторы

NCT: NCT07453212 · 10840098-202.3.02-444

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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