Not Yet RecruitingNot Applicable

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

100 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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:
✕. 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.

What they're measuring

Assessment of bacterial loads

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

Trial details

NCT IDNCT07418333

SponsorVISUfarma SpA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

Anna Rita Bigioni, PhD

00393492862271 a.bigioni@crolife.eu

View on ClinicalTrials.gov More Cataract Surgery trials