MedTrace Logo

Sterile Plant-Based Gauze for Eyelid Hygiene in Anterior Blepharitis

NCT07759180 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Blepharitis

Interventions

DEVICE

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.

DEVICE

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

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER

  • Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

    lead OTHER

Principal Investigators

  • Mario Troisi, MD · Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2025-11-26
Completion
2025-12-12

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07759180 on ClinicalTrials.gov