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The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are:
Participants will be asked to:
Researchers will compare BUFY01 to SVS20 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BUFY01 | Experimental | 0.18% Sodium Hyaluronate (trometamol buffer) in single-dose containers of 0.3 mL |
|
| SVS20 | Active Comparator | 0.18% Sodium Hyaluronate (phosphate buffer) in single-dose containers of 0.3 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BUFY01 eye drops in single-dose containers | Device | 1 to 2 drops in each eye, as often as needed |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Signs | Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome) | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms | Change from baseline in Ocular Surface Disease Index | Day 28 |
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Inclusion Criteria includes:
Exclusion Criteria includes:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital des Quinze-Vingts | Recruiting | Paris | France |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| SVS20 eye drops in single-dose containers |
| Device |
1 to 2 drops in each eye, as often as needed |
|
| CHU Saint-Etienne | Recruiting | Saint-Priest-en-Jarez | France |
|