Dry Eye Disease (DED)NCT07369375
Efficacy and Safety of VMX Eye Drops for Dry Eye Disease
A study testing VMX Eye Drops in people with Dry Eye Disease (DED), run by VISUfarma SpA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- VMX Eye Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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)
- Being tested
- VMX Eye Drops, placebo eye drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMX Eye DropsDevice
VMX ophthalmic solution; the dosage is one drop in each eye three times a day for 56 days.
placebo eye dropsDevice
Sterile ophthalmic solution. The dosage is one drop in each eye three times a day for 56 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group - VMX Eye Drops | Active comparator | Not described Receives: Device: VMX Eye Drops |
| Placebo Group - Placebo Eye Drops | Placebo comparator | Not described Receives: Device: placebo eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break-up Time (TBUT)
Assessment of the change in Tear Break-up Time (TBUT) at V3 versus V1 in the two groups.
Measured: From Baseline (V1) to Visit 3 (V3 - Day 56 after first administration)
Secondary outcomes (6)
Tear Break-up Time (TBUT)
Assessment of Tear Break-up Time (TBUT) at V2 compared to V1 in the two groups.
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: From first administration to Visit 3 (V3 - Day 57 after first administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start2 Feb 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CROlife
- Responsible party
- Sponsor
- Investigators
- Anna R Bigioni, Study chair, CROlife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369375
- Sponsor's protocol ID
- VMX-10-24
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07369375
- Acronym / sponsor ID
- VMX-10-24
- Conditions
- Dry Eye Disease (DED)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Collaborators
- CROlife
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group - VMX Eye Drops | Active comparator | Device: VMX Eye Drops |
| Placebo Group - Placebo Eye Drops | Placebo comparator | Device: placebo eye drops |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Patients not treated with artificial tears for at least 7 days
- Patients not treated with artificial tears for at least 7 days
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VMX Eye DropsVMX ophthalmic solution; the dosage is one drop in each eye three times a day for 56 days. | Device | Treatment Group - VMX Eye Drops |
| placebo eye dropsSterile ophthalmic solution. The dosage is one drop in each eye three times a day for 56 days. | Device | Placebo Group - Placebo Eye Drops |
Primary outcome
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.
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna R Bigioni study chair
CROlife
Questions about this trial
What is this clinical trial studying?
A study testing VMX Eye Drops in people with Dry Eye Disease (DED), run by VISUfarma SpA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Bigioni R PhD (00393492862271, a.bigioni@crolife.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Break-up Time (TBUT) (time frame: From Baseline (V1) to Visit 3 (V3 - Day 56 after first administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.