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

NCT07418333 | Not Yet Recruiting

• 1 other identifier: EPD-09-25
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cataract Surgery; Ocular Infections

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

• Tear Break-up Time (TBUT)

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

• Dry eye symptoms

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

• Assessment of bacterial loads

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

• Identification of the microbiota profile for Eyelid

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

• Adverse Events

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

Study Arms (2)

Treatment group: EPD-09-25 Eyelid wipes

EXPERIMENTAL

EPD eyelid wipes

Device: EPD Eyelid wipes

Control group

NO INTERVENTION

Eyelid hygiene will not be performed before or after eye surgery. The control group will receive only standard therapy for cataract surgery.

Interventions

EPD Eyelid wipes DEVICE

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).

Treatment group: EPD-09-25 Eyelid wipes

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• VISUfarma SpA: lead

MeSH Terms

Conditions

Eye Infections

Condition Hierarchy (Ancestors)

Infections; Eye Diseases

Study Officials

• Anna Rita Bigioni

  CROlife srl

  STUDY CHAIR

Central Study Contacts

Anna Rita Bigioni, PhD

CONTACT

00393492862271; a.bigioni@crolife.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share