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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract Surgery; Ocular Infections
• Intervention / Treatment: Device: EPD Eyelid wipes

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Rita Bigioni, PhD; Phone Number: 00393492862271; Email: a.bigioni@crolife.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. 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.
3. Active or uncontrolled ocular allergy (e.g. allergic conjunctivitis, keratoconjunctivitis) within 4 weeks prior to screening or requiring therapy during the study.
4. Ongoing ocular or systemic infectious (bacterial, viral or fungal) or suspected infection at screening.
5. Recurrent bacterial conjunctivitis (at least once a month in the last 6 months)
6. Any intraocular surgery within 12 months prior to screening or planned intraocular surgery during the study (other than the cataract procedure under study).
7. 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.
8. Eyelid surgery within the 6 months prior to study enrolment.
9. 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.
10. History of ocular herpetic keratitis or active blepharitis, demodex infestation or ocular rosacea within 4 weeks prior to study enrolment.
11. History of autoimmune diseases requiring systemic immunosuppressive therapy.
12. Clinically significant eyelid malposition or mechanical abnormalities, in accordance with PI's clinical judgment.
13. History of corneal diseases (e.g., keratoconus, keratitis, keratoconjunctivitis, corneal dystrophies, permanent damage due to corneal ulcer)
14. History of corneal transplant in one or both eyes
15. Keratinization of the eyelid margin
16. History of Sjögren's syndrome
17. History of corneal trauma within 4 weeks prior to study enrolment.
18. Inability to self-administer study device or absence of a caregiver able to assist with administration medication.
19. 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.
20. Known hypersensitivity to any of the investigational device components (e.g. PQ-133, Gombo, Kolliphor, etc) or wipes materials.
21. Legally or mentally incapacitated participants are unable to provide written informed consent.
22. Participants are unable or unwilling to comply with scheduled visits, procedures, or protocol requirements.
23. Chronic use of topical ocular hypotensive medications (e.g., for glaucoma).
24. Patients undergoing intravitreal injections.
25. 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.
26. Use of contact lenses within 2 weeks prior to screening or planned use during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Eyelid hygiene will not be performed before or after eye surgery. The control group will receive only standard therapy for cataract surgery.
Experimental: Treatment group: EPD-09-25 Eyelid wipes; EPD eyelid wipes	Device: EPD Eyelid wipes; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of bacterial loads	Assessment of bacterial loads in terms of % CFU/Sample at Visit 1 compared with Visit 0 in the two groups.	From Visit 0 (screening and baseline visit) to Visit 1 (Day of the cataract surgery).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From Visit 2 (1 week after cataract surgery) to Visit 3 (4 weeks after cataract surgery)
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.	From Visit 1 (day of the cataract surgery) to Visit 2 (1 week after cataract surgery)
Assessment of bacterial loads	Assessment of bacterial loads in terms of CFU/Sample at Visit 2 compared with Visit 0 in the two groups.	From Visit 0 (screening and baseline visit) to Visit 2 (1 week post cataract surgery)
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).	At Visit 0 (screening and baseline visit) and Visit 1 (day of the cataract surgery)
Adverse Events	Quantitative and Qualitative Evaluation of Safety in terms of Adverse Events reported.	From Visit 0 (screening and baselinevisit) to Visit 3 (4 weeks after cataract surgery)

Collaborators and Investigators

• Sponsor: VISUfarma SpA
• Investigators: Study Chair: Anna Rita Bigioni, CROlife srl

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Eye Infections
• Other Study ID Numbers: EPD-09-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No