A Prospective Randomized Controlled Trial of a Sterile Gauze Containing Natural Plant Extracts (Leniben®) for Eyelid Hygiene in Patients With Bilateral Anterior Blepharitis

Anterior blepharitis is a chronic inflammatory disorder of the eyelid margin characterized by erythema, scaling, crusting, and ocular discomfort. The condition is frequently associated with increased bacterial colonization of the eyelid margin, particularly by Staphylococcus aureus and coagulase-negative staphylococci, which contribute to chronic inflammation through the production of lipases, proteases, and other virulence factors. Bacterial biofilm formation further promotes microbial persistence and recurrent disease, making eyelid hygiene a fundamental component of long-term management.

Although mechanical cleansing of the eyelid margin is widely recommended, limited clinical evidence is available regarding the immediate microbiological efficacy of sterile eyelid cleansing devices containing natural plant-derived compounds. Leniben® Gauze is a sterile single-use cotton gauze impregnated with sodium hyaluronate, Echinacea angustifolia extract, Ananas sativus extract (bromelain), ammonium glycyrrhizate, and tocopherol. The device is intended to combine the mechanical removal of eyelid debris and microbial biofilm with the moisturizing and soothing properties of its active ingredients.

This prospective, randomized, paired-eye controlled clinical trial is designed to evaluate the microbiological efficacy of Leniben® Gauze in adults with bilateral anterior blepharitis. Each participant serves as his or her own control: the right eye receives treatment with Leniben® Gauze, while the contralateral eye is treated with an identical sterile cotton gauze moistened with sterile saline solution. This paired-eye design minimizes inter-individual variability in eyelid microbiota and allows direct comparison between the active formulation and mechanical cleansing alone.

Microbiological samples are collected from the upper and lower eyelid margins of both eyes immediately before treatment and 20 minutes after the cleansing procedure. Samples are cultured using standard microbiological techniques, and bacterial growth is quantified as colony-forming units (CFU). Changes in bacterial load and bacterial eradication rates are compared between treatments. Participant-reported tolerability and any treatment-related adverse events are also assessed.

The results of this study will provide evidence on the ability of a plant-based sterile eyelid cleansing device to reduce periocular bacterial colonization and may support its use as a non-antibiotic adjunctive strategy for eyelid hygiene in anterior blepharitis and for reducing bacterial burden before ophthalmic procedures.