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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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).
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).
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)
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)
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)
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)
Adverse Events
Quantitative and Qualitative Evaluation of Safety in terms of Adverse Events reported.
Time frame: From Visit 0 (screening and baselinevisit) to Visit 3 (4 weeks after cataract surgery)
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