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The goal of this prospective, non-randomized, non-comparative, monocentric PMCF study is to assess the performance of a new preservative-free combination of trehalose, sodium hyaluronate and NAAGA on DED at 6 months in 30 patients having dry eye disease.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group | Experimental | Groupe receiving T2769 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2769 | Device | Preservative-free combination of trehalose, sodium hyaluronate and N-acetyl-aspartyl-glutamate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 | Improvement of DED signs and symptoms at 6 months (M6) according to Ocular Surface Disease Index (OSDI) score change from baseline to M6 OSDI is a 12-item scale with total score from 0 to 100 (Mild 13-22; moderate 23-32; severe 33-100) | at baseline, at 3 months, at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Systemic/non Ophthalmic Exclusion Criteria
Specific Exclusion Criteria Regarding Childbearing Potential Women
Exclusion Criteria Related to General Conditions
Exclusion criteria related to previous and concomitant treatments (medications/non-medicinal therapies/procedures)
• Participant with previous, current or anticipated prohibited listed treatment (or prohibited modification of treatment regimen).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Contact | +33473981436 | Florence.NOIRT@theapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Practice Outpatient Clinic for Specialized Medical | Recruiting | Varna | 9002 | Bulgaria |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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T2769
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