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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
VMX ophthalmic solution; the dosage is one drop in each eye three times a day for 56 days.
Sterile ophthalmic solution. The dosage is one drop in each eye three times a day for 56 days.
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)
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)
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)
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)
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)
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)
Time frame: 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.
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Time frame: From first administration to Visit 3 (V3 - Day 57 after first administration)