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Enrolling By Invitation
NCT07453212
Microbiome-Focused Food Supplement for Evaporative Dry Eye Due to Meibomian Gland Dysfunction
Conditions: Dry Eye, Evaporative Dry Eye Disease, Meibomian Gland Dysfunction (Disorder)
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: Varol TUNALI
Location: T.C. İstanbul Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi Istanbul
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 Criteria
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) \
Source: ClinicalTrials.gov (NCT07453212). StuddyBuddy aggregates publicly available trial information.