An interventional study of Plant-Based Sterile Eyelid Gauze and Sterile Cotton Gauze Moistened with Saline Solution in Blepharitis, sponsored by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona · Not applicable, Interventional, and Treatment
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:
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:
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.
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.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A sterile single-use 100% cotton gauze impregnated with a solution containing sodium hyaluronate, Echinacea angustifolia extract, Ananas sativus extract (bromelain), ammonium glycyrrhizate, and tocopherol.
Device: Plant-Based Sterile Eyelid Gauze
A sterile single-use 100% cotton gauze moistened with sterile saline solution and containing no active ingredients.
Device: Sterile Cotton Gauze Moistened with Saline Solution
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.
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
Difference in Post-Treatment Eyelid Bacterial Load Adjusted for Baseline
Baseline-adjusted difference in total eyelid-margin bacterial load 20 minutes after cleansing between eyes treated with a sterile gauze containing natural plant extracts and contralateral eyes treated with sterile saline-moistened gauze. Total bacterial load is defined as the sum of colony-forming units per milliliter (CFU/mL) of all bacterial species isolated from each eye and analyzed after log₁₀(CFU/mL + 1) transformation.
Time frame: Baseline and 20 minutes after a single treatment
Culture-Negative Conversion
Proportion of eyes with a positive baseline culture that convert to no detectable bacterial growth 20 minutes after treatment. Culture-negative conversion is defined as the transition from a positive baseline culture to no detectable bacterial growth after cleansing.
Time frame: 20 minutes after a single treatment
Percentage Reduction in Eyelid Bacterial Load
Percentage reduction in total bacterial load from baseline to 20 minutes after treatment, calculated only for eyes with a positive baseline culture. Total bacterial load is expressed as colony-forming units per milliliter (CFU/mL).
Time frame: Baseline and 20 minutes after a single treatment
Changes in Eyelid Microbiological Profile
Qualitative and quantitative changes in bacterial species isolated from eyelid-margin cultures, including persistence, clearance, or changes in polymicrobial colonization after treatment. Species-specific analyses are exploratory.
Time frame: Baseline and 20 minutes after a single treatment
Treatment Comfort and Tolerability
Participant-reported ocular comfort, treatment tolerability, and overall acceptability assessed immediately after treatment using 5-point Likert scales, where 1 = very uncomfortable, 2 = uncomfortable, 3 = neutral, 4 = comfortable, and 5 = very comfortable. Higher scores indicate greater treatment comfort and tolerability.
Time frame: Immediately after treatment
Treatment-Related Adverse Events
Incidence of ocular or periocular adverse events, including burning, stinging, itching, tearing, blurred vision, conjunctival hyperemia, eyelid erythema or edema, and corneal epithelial abnormalities occurring after treatment.
Time frame: From treatment administration until completion of the study visit (20 minutes)
Plan to share: Yes — De-identified individual participant data underlying the results reported in the published article will be shared. This will include demographic characteristics, baseline clinical findings, microbiological culture results, quantitative bacterial load (CFU/mL), treatment allocation, outcome measures, and adverse event data necessary to reproduce the published analyses.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Beginning in August 2026 and available indefinitely.
Access criteria: De-identified individual participant data, the study protocol, statistical analysis plan, and statistical code will be available to qualified researchers upon reasonable request to the corresponding author. Access will be granted following review and approval by the study investigators and execution of a data-sharing agreement to ensure participant confidentiality and compliance with institutional and applicable data protection regulations.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona