Clinical Trial

Sterile Plant-Based Gauze for Eyelid Hygiene in Anterior Blepharitis

Study acronym: BLEPH-GAUZE
Completed
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Summary
The goal of this clinical trial is to learn whether a sterile gauze containing natural plant extracts can lower the number of bacteria on the eyelid margin in people with bilateral anterior blepharitis. The study will also evaluate whether the product is safe and well tolerated after a single application. The main questions it aims to answer are: * Does the sterile gauze containing natural plant extracts reduce the bacterial load on the eyelid margin more than a standard sterile gauze? * Does the treatment improve eyelid comfort without causing unwanted side effects? Researchers will compare the study gauze with a sterile gauze without active ingredients. Each participant will receive both treatments: the right eye will be treated with the study gauze, while the left eye will be treated with the control gauze. This allows each participant to serve as their own control. Participants will: * Attend one study visit. * Undergo an eye examination to confirm the diagnosis of bilateral anterior blepharitis. * Have samples collected from the upper and lower eyelid margins of both eyes before treatment. * Receive eyelid cleansing with the assigned gauze for each eye. * Have eyelid samples collected again 20 minutes after treatment. * Complete a short questionnaire about treatment comfort and tolerability. The study will compare the change in bacterial growth between the two eyes to determine whether the natural plant-based gauze provides additional microbiological benefits beyond mechanical eyelid cleansing alone. Safety and participant comfort will also be assessed.
Trial Details
NCT Number NCT07759180
Lead Sponsor Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Collaborators: Federico II University
Conditions Blepharitis
Enrollment 38 participants
Start Date 2023-02-02
Primary Completion 2025-11-26 (estimated)
Study Completion 2025-12-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-12