Health TrialsbyHealthPanel

Efficacy and Safety of VMX Eye Drops for Dry Eye Disease

ConditionDry Eye Disease (DED)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVISUfarma SpA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with an age of ≥ 18 and ≤ 80 years

Tear Osmolarity >308 mOsm/L

TBUT < 10 seconds

Schirmer I test ≥ 5 mm and ≤ 14 mm at 5 minutes

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • VMX Eye Drops

    Device

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

  • placebo eye drops

    Device

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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Treatment Group - VMX Eye DropsActive comparator 1 intervention
Group B: Placebo Group - Placebo Eye DropsPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
From Baseline (V1) to Visit 3 (V3 - Day 56 after first administration)

Secondary outcomes

1

Tear Break-up Time (TBUT)

Assessment of Tear Break-up Time (TBUT) at V2 compared to V1 in the two groups.

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

Schirmer I test

Assessment of Schirmer I test at V2, and V3 compared to V1 in the two groups

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

Tear Osmolarity

Assessment of Tear Osmolarity at V2, and V3 compared to V1 in the two groups

Time frame
From Baseline (V1) to Visit 3 (V3 - Day 57 after first administration)
4

Ocular Surface Disease Index (OSDI) Questionnaire

Assessment of Dry Eye symptoms at V1, V2 and V3, using the Ocular Surface Disease Index (OSDI) Questionnaire

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VISUfarma SpA

Lead sponsor

CROlife

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: