Efficacy and Safety of VMX Eye Drops for Dry Eye Disease
ConditionDry Eye Disease (DED)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVISUfarma SpA
About this trial
This multicenter, randomized, double-blind study evaluates the safety and effectiveness of VMX eye drops in patients with dry eye disease. It aims to improve tear film stability, reduce dry eye symptoms, and enhance patients' quality of life compared to standard treatment.
Eligibility criteria
Qualifiers
Patients with an age of ≥ 18 and ≤ 80 years
Tear Osmolarity >308 mOsm/L
TBUT < 10 seconds
Schirmer I test ≥ 5 mm and ≤ 14 mm at 5 minutes
Disqualifiers
Use of systemic medications which may affect a dry eye condition within 1 month prior to study enrolment (e.g. low-dose aspirin, antihistamines, decongestants, antipsychotics, parkinsonism medications, anticholinergics, oral isotretinoin, and oral diazepam)
Patients with a score of ≤ 4 mm at 5 minutes on the Schirmer I test
Patients that suffer of ocular allergy pathology (seasonal and chronic)
Ongoing ocular or systemic infectious conditions
Trial design
Treatments tested in this trial
- VMX Eye Drops
- placebo eye drops
Treatment groups
76 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
VISUfarma SpA
Lead sponsor
CROlife
Collaborator
Source ClinicalTrials.gov