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
Qualifiers
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
Treatments tested in this trial
- EPD Eyelid wipes
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov