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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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).

Первичные конечные точки

• Assessment of bacterial loads [Срок оценки: From Visit 0 (screening and baseline visit) to Visit 1 (Day of the cataract surgery).]

Вторичные конечные точки (5)

• Tear Break-up Time (TBUT) [Срок оценки: From Visit 2 (1 week after cataract surgery) to Visit 3 (4 weeks after cataract surgery)]
• Dry eye symptoms [Срок оценки: From Visit 1 (day of the cataract surgery) to Visit 2 (1 week after cataract surgery)]
• Assessment of bacterial loads [Срок оценки: From Visit 0 (screening and baseline visit) to Visit 2 (1 week post cataract surgery)]
• Identification of the microbiota profile for Eyelid [Срок оценки: At Visit 0 (screening and baseline visit) and Visit 1 (day of the cataract surgery)]
• Adverse Events [Срок оценки: From Visit 0 (screening and baselinevisit) to Visit 3 (4 weeks after cataract surgery)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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).
• Patients undergoing intravitreal injections.
• 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.
• Use of contact lenses within 2 weeks prior to screening or planned use during the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07418333 · EPD-09-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗