Efficacy and Safety of VMX Eye Drops for Dry Eye Disease (NCT07369375) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of VMX Eye Drops for Dry Eye Disease
76 participantsStarted 2026-02-02
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 herp…
What they're measuring
1
Tear Break-up Time (TBUT)
Timeframe: From Baseline (V1) to Visit 3 (V3 - Day 56 after first administration)