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Completed NCT07759180

Sterile Plant-Based Gauze for Eyelid Hygiene in Anterior Blepharitis

Conditions: Blepharitis

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 38
Sponsor: Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Location: Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona Salerno Campania

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.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 years or older. * Clinical diagnosis of bilateral anterior blepharitis confirmed by slit-lamp examination. * Presence in both eyes of eyelid-margin inflammation associated with at least two of the following clinical signs: eyelid-margin hyperemia; eyelash crusting or collarettes; scaling or debris at the base of the eyelashes; lash abnormalities; mucocutaneous inflammation. * Presence of at least one associated symptom, including burning, itching, foreign-body sensation, tearing, or ocular irritation. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Active ocular infection other than anterior blepharitis. * Predominantly posterior blepharitis requiring specific treatment. * Clinically evident Demodex infestation. * Ocular surgery within the previous 3 months. * Contact lens wear. * Use of topical or systemic antibiotics, antiseptics, or corticosteroids within the previous 4 weeks. * Ocular trauma. * Autoimmune disease or immunodeficiency. * Pregnancy or breastfeeding. * Known hypersensitivity to any component of the study products.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07759180). StuddyBuddy aggregates publicly available trial information.