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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01292-43 | Registry Identifier | Agence Nationale de Sécurité du Médicament et des produits de santé |
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Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2762 | Experimental |
| |
| Vismed® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2762 | Device | 1 drop in each eye 3 to 6 times daily during 84 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Global Ocular Staining (With Oxford Scale - Ranges : 0-15) | Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed). | Baseline and Day 35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont-Ferrand | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | T2762 | T2762: 1 drop in each eye 3 to 6 times daily during 84 days |
| FG001 | Vismed® | Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T2762 | T2762: 1 drop in each eye 3 to 6 times daily during 84 days |
| BG001 | Vismed® | Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Global Ocular Staining (With Oxford Scale - Ranges : 0-15) | Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed). | 14 patients with major protocol deviations were excluded of the analysed population. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Day 35 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | T2762 | T2762: 1 drop in each eye 3 to 6 times daily during 84 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pascale Pouliquen | Laboratoires Théa | 04 73 98 14 36 | p.pouliquen@laboratoires-thea.fr |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Vismed® |
| Device |
1 drop in each eye 3 to 6 times daily during 84 days |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Vismed® | Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days | 0 | 53 | 0 | 53 |
All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever from without prior written agreement of THEA