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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003567-39 | EudraCT Number |
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Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent bacterial conjunctivitis of children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T1225 | Experimental |
| |
| Tobramycin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T1225 | Drug | one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 | Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale). | Day 3 |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clermont-Ferrand | 63000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | T1225 | T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 |
| FG001 | Tobramycin | Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | T1225 | T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 |
| BG001 | Tobramycin | Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6 |
| 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 | The Primary Efficacy Variable Was Clinical Cure in the Worse Eye on Day 3 | Clinical cure was defined as a score 0 for bulbar conjunctival injection (evaluated using a 4 point ordinal scale) and a score 0 for conjunctival purulent discharge (evaluated using a 4 point ordinal scale). | The analysis of the primary clinical efficacy variable was primarily performed on the basis of the MFAS. The MFAS consisted of all patients of the FAS with positive Day 0 culture results in an eligible eye. | Posted | Number | participants | Day 3 |
|
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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 | T1225 | T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pascale Pouliquen (Medical director) | Laboratoires Thea | 0473963614 | p.pouliquen@laboratoires-thea.fr |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
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| Tobramycin |
| Drug |
1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6 |
|
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
|
|
| 0 |
| 146 |
| 0 |
| 146 |
| EG001 | Tobramycin | Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6 | 0 | 140 | 0 | 140 |
All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
| Carbohydrates |