Efficacy and Safety of VMX Eye Drops for Dry Eye Disease

Inclusion criteria

• Patients with an age of ≥ 18 and ≤ 80 years
• Patients with a diagnosis of Dry Eye (mild/moderate) with at least one of the following:

• Tear Osmolarity >308 mOsm/L
• TBUT < 10 seconds
• Schirmer I test ≥ 5 mm and ≤ 14 mm at 5 minutes
• Patients not treated with artificial tears for at least 7 days
• Patients not treated with artificial tears for at least 7 days

Exclusion criteria

• 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
• Use of topical ocular therapies that cannot be suspended for the entire duration of the study
• Use of topical antibiotics and or corticosteroids within 15 days prior to study enrolment
• Use of systemic antibiotics and or corticosteroids within 1 month prior to study enrolment
• Any intraocular surgery in the past 12 months or require any intraocular surgery during the study
• Acute and Chronic Conjunctival Disease
• Eyelid surgery within the 6 months prior to study enrolment
• Presence of congenitally absent lacrimal or Meibomian glands or have any obstructive disease of the lacrimal glands
• History of ocular herpetic keratitis or active blepharitis in the 4 weeks prior to study enrolment
• History of autoimmune diseases
• Inflammations or abnormalities in the eyelid, in accordance with PI's clinical judgment
• History of corneal diseases, as keratoconus
• History of corneal transplant in one or both eyes
• Keratinization of the eyelid margin
• History of Sjögren's syndrome
• History of corneal trauma in the last 4 weeks prior to study enrolment
• Patients who are unwilling to discontinue all artificial tears and use only the study product ad indicated for the duration of the study
• Inability to self-administer study medications
• Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.
• Any hypersensitivity to the use of the study product formulations or an allergy to any ingredients contained within product formulation
• Participation in other clinical studies involving drugs or devices within 30 days prior to study enrolment.
• Patients legally or mentally incapacitated unable to give informed consent for the participation in this trial
• Patients unable or unwilling to comply with appointments or all protocol requirements