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Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2750 | Experimental |
| |
| Vismed | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T2750 | 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) | Baseline and 35 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paris | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | T2750 | T2750: 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 | T2750 | T2750: 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, Continuous | Mean |
| 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) | Per Protocol Population | Posted | Mean | Standard Deviation | scores on a scale | Baseline and 35 days |
|
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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 | T2750 | T2750: 1 drop in each eye 3 to 6 times daily during 84 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (15.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Pascale POULIQUEN | Laboratoires Thea | 0473981436 | 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 |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Time from the dry eye diagnosis | Mean | Standard Deviation | years |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 1 |
| 48 |
| 0 |
| 48 |
| EG001 | Vismed | Vismed: 1 drop in each eye 3 to 6 times daily during 84 days | 0 | 45 | 0 | 45 |
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