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Cataract SurgeryNCT07418333

Efficacy of EPD-09-25 for Eyelid Hygiene Before and After Eye Surgery.

A study testing EPD Eyelid wipes in people with Cataract Surgery and Ocular Infections, run by VISUfarma SpA.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is an interventional, open-label, two-arms clinical trial, randomized 1:1 (EPD treatment or no eyelid hygiene treatment) in patients scheduled for eye surgery (cataract surgery). The purpose of the study is to evaluate the importance of the cleansing action of EPD-09-25 before and after eye surgery. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Cataract Surgery, Ocular Infections
What is being tested?
EPD Eyelid wipes
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
1 Apr 2026to 1 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female adults aged ≥ 18 and ≤ 85 years.
  • Clinical diagnosis of cataract scheduled for cataract surgery.
  • Provision of written informed consent as approved by the Ethics Committee (EC).

Who cannot join

  • Patients with DED and MGD, before cataract surgery, confirmed at Visit 0 (screening and baseline). At least one of the following conditions (in the eye subjected to cataract surgery) must be met:
  • TBUT < 10s
  • SPEED score > 4
  • Recent (≤8 weeks) use or dose adjustment of systemic medications known to affect tear film or lacrimal section systemic antihistamines, antidepressant such as SSRI/SNRI/TCA, antiparkinsonian agents, anticholinergics, oral isotretinoin.
  • Active or uncontrolled ocular allergy (e.g. allergic conjunctivitis, keratoconjunctivitis) within 4 weeks prior to screening or requiring therapy during the study.
  • Ongoing ocular or systemic infectious (bacterial, viral or fungal) or suspected infection at screening.
Show all 28Show fewer
  • Recurrent bacterial conjunctivitis (at least once a month in the last 6 months)
  • Any intraocular surgery within 12 months prior to screening or planned intraocular surgery during the study (other than the cataract procedure under study).
  • Acute (active at the screening and baseline visit) or Chronic (persistent) Conjunctival Disease (e.g., symptomatic pterygium, cicatricial conjunctivitis); conditions that may alter the ocular surface and influence the assessment of symptoms.
  • Eyelid surgery within the 6 months prior to study enrolment.
  • Congenital absence (genetic defect) of lacrimal or Meibomian glands or clinically significant obstruction of the lacrimal glands (blockage of the tear drainage system (e.g. nasolacrimal duct stenosis) which can cause excessive tearing or alter the distribution of the tear film.
  • History of ocular herpetic keratitis or active blepharitis, demodex infestation or ocular rosacea within 4 weeks prior to study enrolment.
  • History of autoimmune diseases requiring systemic immunosuppressive therapy.
  • Clinically significant eyelid malposition or mechanical abnormalities, in accordance with PI's clinical judgment.
  • History of corneal diseases (e.g., keratoconus, keratitis, keratoconjunctivitis, corneal dystrophies, permanent damage due to corneal ulcer)
  • History of corneal transplant in one or both eyes
  • Keratinization of the eyelid margin
  • History of Sjögren's syndrome
  • History of corneal trauma within 4 weeks prior to study enrolment.
  • Inability to self-administer study device or absence of a caregiver able to assist with administration medication.
  • Women of childbearing potential who are pregnant, breastfeeding, planning to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.
  • Known hypersensitivity to any of the investigational device components (e.g. PQ-133, Gombo, Kolliphor, etc) or wipes materials.
  • Legally or mentally incapacitated participants are unable to provide written informed consent.
  • Participants are unable or unwilling to comply with scheduled visits, procedures, or protocol requirements.
  • Chronic use of topical ocular hypotensive medications (e.g., for glaucoma).
  • Patients undergoing intravitreal injections.
  • Recent use (≤4 weeks) of topical or systemic therapies for DED/MGD that could confound efficacy outcomes, including cyclosporine, lifitegrast, prolonged topical corticosteroids, autologous serum, or procedural treatments such as IPL, LipiFlow, or similar interventions within the past 3-6 months, or punctal plugs placed within 3 months.
  • Use of contact lenses within 2 weeks prior to screening or planned use during the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Anna Rita Bigioni, PhD contact

00393492862271

a.bigioni@crolife.eu

About this study

Official title: Open-label, Randomized, Two-arms Interventional Clinical Trial to Evaluate the Importance of the Cleansing Action of EPD-09-25 Before and After Eye Surgery

This is an interventional, open-label, two-arms clinical trial, randomized 1:1 (EPD treatment or no eyelid hygiene treatment) in patients scheduled for eye surgery (cataract surgery). The purpose of the study is to evaluate the importance of the cleansing action of EPD-09-25 before and after eye surgery.

Being tested
EPD Eyelid wipes
Medical subject headings
Eye Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPD Eyelid wipesDevice

    One wipe will be applied to the eyelid margin and eyelashes of the affected eye (subjected to cataract surgery), 2 times daily for 5 weeks (1 week before the cataract surgery and 4 weeks post cataract surgery).

Study groups in NCT07418333
Study groupRoleWhat they receive
Treatment group: EPD-09-25 Eyelid wipesExperimentalEPD eyelid wipes
Receives: Device: EPD Eyelid wipes
Control groupNo interventionEyelid hygiene will not be performed before or after eye surgery. The control group will receive only standard therapy for cataract surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of bacterial loads

    Assessment of bacterial loads in terms of % CFU/Sample at Visit 1 compared with Visit 0 in the two groups.

    Measured: From Visit 0 (screening and baseline visit) to Visit 1 (Day of the cataract surgery).

Secondary outcomes (5)

  1. Tear Break-up Time (TBUT)

    Assessment of the change in Tear Break-up Time (TBUT) at Visit 3 compared with Visit 2 in the two groups.

    Measured: From Visit 2 (1 week after cataract surgery) to Visit 3 (4 weeks after cataract surgery)

  2. Dry eye symptoms

    The number of subjects with dry eye symptoms at Visit 2 (1 week post cataract surgery) compared to Visit 1 in the two study groups, using the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire.

    Measured: From Visit 1 (day of the cataract surgery) to Visit 2 (1 week after cataract surgery)

  3. Assessment of bacterial loads

    Assessment of bacterial loads in terms of CFU/Sample at Visit 2 compared with Visit 0 in the two groups.

    Measured: From Visit 0 (screening and baseline visit) to Visit 2 (1 week post cataract surgery)

  4. Identification of the microbiota profile for Eyelid

    Identification of the microbiota profile for Eyelid at Visit 0 and Visit 1 (most frequent microorganisms: Staphylococcus epidermidis; Corynebacterium spp; Staphylococcus aureus; Micrococcus spp; Bacillus spp).

    Measured: At Visit 0 (screening and baseline visit) and Visit 1 (day of the cataract surgery)

  5. Adverse Events

    Quantitative and Qualitative Evaluation of Safety in terms of Adverse Events reported.

    Measured: From Visit 0 (screening and baselinevisit) to Visit 3 (4 weeks after cataract surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Nov 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07418333
Sponsor's protocol ID
EPD-09-25
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
20 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing EPD Eyelid wipes in people with Cataract Surgery and Ocular Infections, run by VISUfarma SpA.

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 3 inclusion and 28 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: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Rita Bigioni, PhD (00393492862271, a.bigioni@crolife.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of bacterial loads (time frame: From Visit 0 (screening and baseline visit) to Visit 1 (Day of the cataract surgery).). 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 NCT07418333.

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 20 Feb 2026.

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