Efficacy of EPD-09-25 for Eyelid Hygiene Before and After Eye Surgery.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorVISUfarma SpA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EPD Eyelid wipes
DeviceOne 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).
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Treatment group: EPD-09-25 Eyelid wipesExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Assessment of bacterial loads
Assessment of bacterial loads in terms of % CFU/Sample at Visit 1 compared with Visit 0 in the two groups.
Time frame
From Visit 0 (screening and baseline visit) to Visit 1 (Day of the cataract surgery).Secondary outcomes
1
Tear Break-up Time (TBUT)
Assessment of the change in Tear Break-up Time (TBUT) at Visit 3 compared with Visit 2 in the two groups.
Time frame
From Visit 2 (1 week after cataract surgery) to Visit 3 (4 weeks after cataract surgery)2
Dry eye symptoms
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.
Time frame
From Visit 1 (day of the cataract surgery) to Visit 2 (1 week after cataract surgery)3
Assessment of bacterial loads
Assessment of bacterial loads in terms of CFU/Sample at Visit 2 compared with Visit 0 in the two groups.
Time frame
From Visit 0 (screening and baseline visit) to Visit 2 (1 week post cataract surgery)4
Identification of the microbiota profile for Eyelid
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).
Time frame
At Visit 0 (screening and baseline visit) and Visit 1 (day of the cataract surgery)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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