Efficacy and Safety of VMX Eye Drops for Dry Eye Disease

January 27, 2026 updated by: VISUfarma SpA

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Treatment Group - VMX Eye Drops
Device: VMX Eye Drops
VMX ophthalmic solution; the dosage is one drop in each eye three times a day for 56 days.
Placebo Comparator: Placebo Group - Placebo Eye Drops
Device: placebo eye drops
Sterile ophthalmic solution. The dosage is one drop in each eye three times a day for 56 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tear Break-up Time (TBUT)
Time Frame: From Baseline (V1) to Visit 3 (V3 - Day 56 after first administration)
Assessment of the change in Tear Break-up Time (TBUT) at V3 versus V1 in the two groups.
From Baseline (V1) to Visit 3 (V3 - Day 56 after first administration)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tear Break-up Time (TBUT)
Time Frame: From Baseline (V1) to Visit 2 (V2 - Day 17 after first administration)
Assessment of Tear Break-up Time (TBUT) at V2 compared to V1 in the two groups.
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)
Assessment of Schirmer I test at V2, and V3 compared to V1 in the two groups
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)
Assessment of Tear Osmolarity at V2, and V3 compared to V1 in the two groups
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)
Assessment of Dry Eye symptoms at V1, V2 and V3, using the Ocular Surface Disease Index (OSDI) Questionnaire
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)
Assessment of Dry Eye symptoms at V1, V2 and V3, using Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED)
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)
Quantitative and Qualitative Evaluation of Safety in terms of Adverse Events reported.
From first administration to Visit 3 (V3 - Day 57 after first administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VISUfarma SpA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CROlife

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Anna R Bigioni, CROlife

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VMX-10-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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