Sterile Plant-Based Gauze for Eyelid Hygiene in Anterior Blepharitis

NCT07759180 | Completed

• 1 other identifier: BLEPH-LENIBEN-001
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anterior blepharitis; eyelid hygiene; eyelid microbiota; eyelid wipes

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 20 minutes after a single treatment

Secondary Outcomes (5)

• Culture-Negative Conversion

  20 minutes after a single treatment

• Percentage Reduction in Eyelid Bacterial Load

  Baseline and 20 minutes after a single treatment

• Changes in Eyelid Microbiological Profile

  Baseline and 20 minutes after a single treatment

• Treatment Comfort and Tolerability

  Immediately after treatment

• Treatment-Related Adverse Events

  From treatment administration until completion of the study visit (20 minutes)

Study Arms (2)

Leniben

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

Plant-Based Sterile Eyelid Gauze DEVICE

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.

Leniben

Sterile Cotton Gauze Moistened with Saline Solution DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona: lead
• Federico II University: collaborator

Study Sites (1)

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

Salerno, Campania, 84125, Italy

Location

Related Publications (7)

• Guillon M, Maissa C, Wong S. Eyelid margin modification associated with eyelid hygiene in anterior blepharitis and meibomian gland dysfunction. Eye Contact Lens. 2012 Sep;38(5):319-25. doi: 10.1097/ICL.0b013e318268305a.

  PMID: 22890229 BACKGROUND

• Shi R, Guo Y, Li A, Tian L, Jie Y. Comparative efficacy of eyelid cleansing wipes, hypochlorous acid, and saline for blepharitis-associated ocular surface disease: a randomized trial. Sci Rep. 2026 Jul 11. doi: 10.1038/s41598-026-62115-z. Online ahead of print.

  PMID: 42436201 BACKGROUND

• Sung J, Wang MTM, Lee SH, Cheung IMY, Ismail S, Sherwin T, Craig JP. Randomized double-masked trial of eyelid cleansing treatments for blepharitis. Ocul Surf. 2018 Jan;16(1):77-83. doi: 10.1016/j.jtos.2017.10.005. Epub 2017 Nov 8.

  PMID: 29128682 BACKGROUND

• Peral A, Alonso J, Garcia-Garcia C, Nino-Rueda C, Calvo Del Bosque P. Importance of Lid Hygiene Before Ocular Surgery: Qualitative and Quantitative Analysis of Eyelid and Conjunctiva Microbiota. Eye Contact Lens. 2016 Nov;42(6):366-370. doi: 10.1097/ICL.0000000000000221.

  PMID: 26657662 BACKGROUND

• Stroman DW, Mintun K, Epstein AB, Brimer CM, Patel CR, Branch JD, Najafi-Tagol K. Reduction in bacterial load using hypochlorous acid hygiene solution on ocular skin. Clin Ophthalmol. 2017 Apr 13;11:707-714. doi: 10.2147/OPTH.S132851. eCollection 2017.

  PMID: 28458509 BACKGROUND

• Giannaccare G, Vagge A, Pellegrini M, Buzzi M, Mencucci R, Lorusso M, Massimino M, Rossi C, Celandroni F, Calvigioni M, Mazzantini D, Nicolo M, Scorcia V, Traverso CE, Ghelardi E. In vitro and in vivo antimicrobial activity of medicated wipes containing biosecur on the microbial Flora of the eyelid and conjunctiva. Eur J Ophthalmol. 2025 Sep;35(5):1810-1817. doi: 10.1177/11206721251332758. Epub 2025 Apr 15.

  PMID: 40232251 BACKGROUND

• Mencucci R, Morelli A, Favuzza E, Galano A, Roszkowska AM, Cennamo M. Hypochlorous acid hygiene solution in patients affected by blepharitis: a prospective randomised study. BMJ Open Ophthalmol. 2023 Dec 7;8(1):e001209. doi: 10.1136/bmjophth-2022-001209.

  PMID: 38088255 BACKGROUND

MeSH Terms

Conditions

Blepharitis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• Mario Troisi, MD

  Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a prospective, randomized, paired-eye controlled trial in which each participant serves as his or her own control. For each participant, one eye was randomly assigned to treatment with Leniben® Gauze containing natural plant extracts, while the contralateral eye was randomly assigned to treatment with an identical sterile cotton gauze moistened with sterile saline. Microbiological outcomes were compared within the same participant, thereby minimizing inter-individual variability in eyelid bacterial colonization and improving the precision of treatment effect estimates.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: This is a prospective, randomized, paired-eye controlled trial in which each participant serves as his or her own control. For each participant, one eye was randomly assigned to treatment with Leniben® Gauze containing natural plant extracts, while the contralateral eye was randomly assigned to treatment with an identical sterile cotton gauze moistened with sterile saline. Microbiological outcomes were compared within the same participant, thereby minimizing inter-individual variability in eyelid bacterial colonization and improving the precision of treatment effect estimates.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 12, 2026
• Study Start: February 2, 2023
• Primary Completion: November 26, 2025
• Study Completion: December 12, 2025
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.

Locations

IT (1)