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Not yet recruiting NCT07369375

Efficacy and Safety of VMX Eye Drops for Dry Eye Disease

No phase Interventional Dry Eye Disease (DED)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VMX Eye Drops, placebo eye drops.
Who it may be relevant to
Registry conditions: Dry Eye Disease (DED). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VMX Eye Drops for the Treatment of Dry Eye Disease (DED)

Overview

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.

Interventions

  • Device VMX Eye Drops
    VMX ophthalmic solution; the dosage is one drop in each eye three times a day for 56 days.
  • Device placebo eye drops
    Sterile ophthalmic solution. The dosage is one drop in each eye three times a day for 56 days.

Primary outcome measures

  • Tear Break-up Time (TBUT) [Time frame: From Baseline (V1) to Visit 3 (V3 - Day 56 after first administration)]
Secondary outcome measures (6)
  • Tear Break-up Time (TBUT) [Time frame: From Baseline (V1) to Visit 2 (V2 - Day 17 after first administration)]
  • Schirmer I test [Time frame: From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration)]
  • Tear Osmolarity [Time frame: From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration)]
  • Ocular Surface Disease Index (OSDI) Questionnaire [Time frame: From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration)]
  • Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) [Time frame: From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration)]
  • Adverse Events [Time frame: From first administration to Visit 3 (V3 - Day 57 after first administration)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07369375 · VMX-10-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗