Efficacy and Safety of VMX Eye Drops for Dry Eye Disease

VISUfarma

Status

Not yet enrolling

Conditions

Dry Eye Disease (DED)

Treatments

Device: VMX Eye Drops

Device: placebo eye drops

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT07369375

VMX-10-24

Details and patient eligibility

About

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.

Enrollment

76 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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