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| Name | Class |
|---|---|
| CROlife | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group - VMX Eye Drops | Active Comparator |
| |
| Placebo Group - Placebo Eye Drops | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VMX Eye Drops | Device | VMX ophthalmic solution; the dosage is one drop in each eye three times a day for 56 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break-up Time (TBUT) | Assessment of Tear Break-up Time (TBUT) at V2 compared to V1 in the two groups. | From Baseline (V1) to Visit 2 (V2 - Day 17 after first administration) |
| Schirmer I test |
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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:
Patients not treated with artificial tears for at least 7 days
Patients not treated with artificial tears for at least 7 days
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Bigioni R PhD | Contact | 00393492862271 | a.bigioni@crolife.eu |
| Name | Affiliation | Role |
|---|---|---|
| Anna R Bigioni | CROlife | Study Chair |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| placebo eye drops | Device | Sterile ophthalmic solution. The dosage is one drop in each eye three times a day for 56 days. |
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Assessment of Schirmer I test at V2, and V3 compared to V1 in the two groups
| 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 | 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 | 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) | 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. | From first administration to Visit 3 (V3 - Day 57 after first administration) |