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Sterile Plant-Based Gauze for Eyelid Hygiene in Anterior Blepharitis
Sponsor: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
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.
Official title: A Prospective Randomized Controlled Trial of a Sterile Gauze Containing Natural Plant Extracts (Leniben®) for Eyelid Hygiene in Patients With Bilateral Anterior Blepharitis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2023-02-02
Completion Date
2025-12-12
Last Updated
2026-08-12
Healthy Volunteers
No
Conditions
Interventions
Plant-Based Sterile Eyelid Gauze
Participants received eyelid hygiene using Leniben® Gauze, a sterile single-use cotton gauze impregnated with a solution containing sodium hyaluronate, Echinacea angustifolia extract, Ananas sativus extract (bromelain), ammonium glycyrrhizate, and tocopherol. One eye of each participant was randomly assigned to the intervention. The upper and lower eyelid margins were cleansed using five standardized strokes, and microbiological samples were collected before treatment and 20 minutes after application to evaluate changes in bacterial colonization.
Sterile Cotton Gauze Moistened with Saline Solution
Participants received eyelid hygiene using an identical sterile single-use cotton gauze moistened with sterile saline solution, without active ingredients. The contralateral eye of each participant was randomly assigned to the control treatment. The upper and lower eyelid margins were cleansed using the same standardized procedure as the experimental arm (five standardized strokes). Microbiological samples were collected before treatment and 20 minutes after application to evaluate changes in bacterial colonization attributable to mechanical cleansing alone
Locations (1)
Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, Campania, Italy