Efficacy and Safety of VMX Eye Drops for Dry Eye Disease

NCT07369375 | Not Yet Recruiting

• 1 other identifier: VMX-10-24
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Tear Break-up Time (TBUT)

  From Baseline (V1) to Visit 2 (V2 - Day 17 after first administration)

• Schirmer I test

  From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration)

• Tear Osmolarity

  From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration)

• 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)

  From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration)

Study Arms (2)

Treatment Group - VMX Eye Drops

ACTIVE COMPARATOR

Device: VMX Eye Drops

Placebo Group - Placebo Eye Drops

PLACEBO COMPARATOR

Device: placebo eye drops

Interventions

VMX Eye Drops DEVICE

VMX ophthalmic solution; the dosage is one drop in each eye three times a day for 56 days.

Treatment Group - VMX Eye Drops

placebo eye drops DEVICE

Sterile ophthalmic solution. The dosage is one drop in each eye three times a day for 56 days.

Placebo Group - Placebo Eye Drops

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VISUfarma SpA: lead
• CROlife: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Anna R Bigioni

  CROlife

  STUDY CHAIR

Central Study Contacts

Anna Bigioni R PhD

CONTACT

00393492862271; a.bigioni@crolife.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 27, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share