Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:06 AM
Study NCT ID:
NCT07418333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of EPD-09-25 for Eyelid Hygiene Before and After Eye Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015817', 'term': 'Eye Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of bacterial loads', 'timeFrame': 'From Visit 0 (screening and baseline visit) to Visit 1 (Day of the cataract surgery).', 'description': 'Assessment of bacterial loads in terms of % CFU/Sample at Visit 1 compared with Visit 0 in the two groups.'}], 'secondaryOutcomes': [{'measure': 'Tear Break-up Time (TBUT)', 'timeFrame': 'From Visit 2 (1 week after cataract surgery) to Visit 3 (4 weeks after cataract surgery)', 'description': 'Assessment of the change in Tear Break-up Time (TBUT) at Visit 3 compared with Visit 2 in the two groups.'}, {'measure': 'Dry eye symptoms', 'timeFrame': 'From Visit 1 (day of the cataract surgery) to Visit 2 (1 week after cataract surgery)', 'description': 'The number of subjects with dry eye symptoms at Visit 2 (1 week post cataract surgery) compared to Visit 1 in the two study groups, using the Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire.'}, {'measure': 'Assessment of bacterial loads', 'timeFrame': 'From Visit 0 (screening and baseline visit) to Visit 2 (1 week post cataract surgery)', 'description': 'Assessment of bacterial loads in terms of CFU/Sample at Visit 2 compared with Visit 0 in the two groups.'}, {'measure': 'Identification of the microbiota profile for Eyelid', 'timeFrame': 'At Visit 0 (screening and baseline visit) and Visit 1 (day of the cataract surgery)', 'description': 'Identification of the microbiota profile for Eyelid at Visit 0 and Visit 1 (most frequent microorganisms: Staphylococcus epidermidis; Corynebacterium spp; Staphylococcus aureus; Micrococcus spp; Bacillus spp).'}, {'measure': 'Adverse Events', 'timeFrame': 'From Visit 0 (screening and baselinevisit) to Visit 3 (4 weeks after cataract surgery)', 'description': 'Quantitative and Qualitative Evaluation of Safety in terms of Adverse Events reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract Surgery', 'Ocular Infections']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and female adults aged ≥ 18 and ≤ 85 years.\n2. Clinical diagnosis of cataract scheduled for cataract surgery.\n3. Provision of written informed consent as approved by the Ethics Committee (EC).\n\nExclusion Criteria:\n\n1. 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:\n\n * TBUT \\< 10s\n * SPEED score \\> 4\n2. 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.\n3. Active or uncontrolled ocular allergy (e.g. allergic conjunctivitis, keratoconjunctivitis) within 4 weeks prior to screening or requiring therapy during the study.\n4. Ongoing ocular or systemic infectious (bacterial, viral or fungal) or suspected infection at screening.\n5. Recurrent bacterial conjunctivitis (at least once a month in the last 6 months)\n6. Any intraocular surgery within 12 months prior to screening or planned intraocular surgery during the study (other than the cataract procedure under study).\n7. 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.\n8. Eyelid surgery within the 6 months prior to study enrolment.\n9. 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.\n10. History of ocular herpetic keratitis or active blepharitis, demodex infestation or ocular rosacea within 4 weeks prior to study enrolment.\n11. History of autoimmune diseases requiring systemic immunosuppressive therapy.\n12. Clinically significant eyelid malposition or mechanical abnormalities, in accordance with PI's clinical judgment.\n13. History of corneal diseases (e.g., keratoconus, keratitis, keratoconjunctivitis, corneal dystrophies, permanent damage due to corneal ulcer)\n14. History of corneal transplant in one or both eyes\n15. Keratinization of the eyelid margin\n16. History of Sjögren's syndrome\n17. History of corneal trauma within 4 weeks prior to study enrolment.\n18. Inability to self-administer study device or absence of a caregiver able to assist with administration medication.\n19. 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.\n20. Known hypersensitivity to any of the investigational device components (e.g. PQ-133, Gombo, Kolliphor, etc) or wipes materials.\n21. Legally or mentally incapacitated participants are unable to provide written informed consent.\n22. Participants are unable or unwilling to comply with scheduled visits, procedures, or protocol requirements.\n23. Chronic use of topical ocular hypotensive medications (e.g., for glaucoma).\n24. Patients undergoing intravitreal injections.\n25. 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.\n26. Use of contact lenses within 2 weeks prior to screening or planned use during the study."}, 'identificationModule': {'nctId': 'NCT07418333', 'briefTitle': 'Efficacy of EPD-09-25 for Eyelid Hygiene Before and After Eye Surgery.', 'organization': {'class': 'INDUSTRY', 'fullName': 'VISUfarma SpA'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'EPD-09-25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group: EPD-09-25 Eyelid wipes', 'description': 'EPD eyelid wipes', 'interventionNames': ['Device: EPD Eyelid wipes']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Eyelid hygiene will not be performed before or after eye surgery. The control group will receive only standard therapy for cataract surgery.'}], 'interventions': [{'name': 'EPD Eyelid wipes', 'type': 'DEVICE', 'description': '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).', 'armGroupLabels': ['Treatment group: EPD-09-25 Eyelid wipes']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anna Rita Bigioni, PhD', 'role': 'CONTACT', 'email': 'a.bigioni@crolife.eu', 'phone': '00393492862271'}], 'overallOfficials': [{'name': 'Anna Rita Bigioni', 'role': 'STUDY_CHAIR', 'affiliation': 'CROlife srl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VISUfarma SpA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}