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

Starting soon · Not applicable

Conditions studied: Cataract Surgery, Ocular Infections

In brief

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.

Key facts

Study ID: NCT07418333
Run by: VISUfarma SpA
People needed: 100
Starts: 2026-04-01
Expected to finish: 2026-11-01
Last updated by the study team: 2026-02-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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)
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).

Full record on ClinicalTrials.gov

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