Efficacy of EPD-09-25 for Eyelid Hygiene Before and After Eye Surgery. (NCT07418333) | Clinical Trial Compass
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 range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of bacterial loads
Timeframe: From Visit 0 (screening and baseline visit) to Visit 1 (Day of the cataract surgery).
. 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.