BlepharitisBLEPH-GAUZENCT07759180
Sterile Plant-Based Gauze for Eyelid Hygiene in Anterior Blepharitis
A study testing Plant-Based Sterile Eyelid Gauze and Sterile Cotton Gauze Moistened with Saline Solution in people with Blepharitis, run by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharitis
- What is being tested?
- Plant-Based Sterile Eyelid Gauze and Sterile Cotton Gauze Moistened with Saline Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2023to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Ocular trauma.
- Autoimmune disease or immunodeficiency.
- Pregnancy or breastfeeding.
- Known hypersensitivity to any component of the study products.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
Salerno, Campania, 84125
About this study
Official title: A Prospective Randomized Controlled Trial of a Sterile Gauze Containing Natural Plant Extracts (Leniben®) for Eyelid Hygiene in Patients With Bilateral Anterior Blepharitis
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Blepharitis
- Being tested
- Plant-Based Sterile Eyelid Gauze, Sterile Cotton Gauze Moistened with Saline Solution
- Keywords
- Anterior blepharitis, eyelid hygiene, eyelid microbiota, eyelid wipes
- Medical subject headings
- Blepharitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant-Based Sterile Eyelid GauzeDevice
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.
Sterile Cotton Gauze Moistened with Saline SolutionDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sterile Cotton Gauze Moistened with Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 20 minutes after a single treatment
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From treatment administration until completion of the study visit (20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start2 Feb 2023
- Primary completion26 Nov 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for BlepharitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Principal investigator, Mario Troisi, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona
- Investigators
- Mario Troisi, MD, Principal investigator, Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759180
- Sponsor's protocol ID
- BLEPH-LENIBEN-001
- Acronym
- BLEPH-GAUZE
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 22890229Shi 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.
PubMed 42436201Sung 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.
PubMed 29128682Peral 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.
PubMed 26657662Stroman 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.
PubMed 28458509Giannaccare 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.
PubMed 40232251Mencucci 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.
PubMed 38088255
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of a Sterile Gauze Containing Natural Plant Extracts (Leniben®) for Eyelid Hygiene in Patients With Bilateral Anterior Blepharitis
- ClinicalTrials.gov ID
- NCT07759180
- Acronym / sponsor ID
- BLEPH-GAUZE / BLEPH-LENIBEN-001
- Conditions
- Blepharitis
- Keywords
- Anterior blepharitis, eyelid hygiene, eyelid microbiota, eyelid wipes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'AragonaUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Leniben | Experimental | Device: Plant-Based Sterile Eyelid GauzeA sterile single-use 100% cotton gauze impregnated with a solution containing sodium hyaluronate, Echinacea angustifolia extract, Ananas sativus extract (bromelain), ammonium glycyrrhizate, and tocopherol. |
| Control | Sham comparator | Device: Sterile Cotton Gauze Moistened with Saline SolutionA sterile single-use 100% cotton gauze moistened with sterile saline solution and containing no active ingredients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant-Based Sterile Eyelid GauzeParticipants 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 | Leniben |
| Sterile Cotton Gauze Moistened with Saline SolutionParticipants 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 | Device | Control |
Primary outcome
Difference in Post-Treatment Eyelid Bacterial Load Adjusted for Baseline
Time frame: Baseline and 20 minutes after a single treatment
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.
5 secondary outcomes
Culture-Negative Conversion
Time frame: 20 minutes after a single treatment
Percentage Reduction in Eyelid Bacterial Load
Time frame: Baseline and 20 minutes after a single treatment
Changes in Eyelid Microbiological Profile
Time frame: Baseline and 20 minutes after a single treatment
Treatment Comfort and Tolerability
Time frame: Immediately after treatment
Treatment-Related Adverse Events
Time frame: From treatment administration until completion of the study visit (20 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 22890229Guillon 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.
- Background: PubMed 42436201Shi 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.
- Background: PubMed 29128682Sung 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.
- Background: PubMed 26657662Peral 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.
- Background: PubMed 28458509Stroman 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.
- Background: PubMed 40232251Giannaccare 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.
- Background: PubMed 38088255Mencucci 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Troisi, MD principal investigator
Azienda Ospedaliera Universitaria OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant-Based Sterile Eyelid Gauze and Sterile Cotton Gauze Moistened with Saline Solution in people with Blepharitis, run by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Post-Treatment Eyelid Bacterial Load Adjusted for Baseline (time frame: Baseline and 20 minutes after a single treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07759180, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.