Efficacy and Safety of VMX Eye Drops for Dry Eye Disease

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: Not yet recruiting
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Device: VMX Eye Drops; Device: placebo eye drops

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Bigioni R PhD; Phone Number: 00393492862271; Email: a.bigioni@crolife.eu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Tear Break-up Time (TBUT)	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

Outcome Measure	Measure Description	Time Frame
Tear Break-up Time (TBUT)	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	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	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	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)	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	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

• Sponsor: VISUfarma SpA
• Collaborators: CROlife
• Investigators: Study Chair: Anna R Bigioni, CROlife

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID 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