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The purpose of this study is to describe the differences in efficacy between TOBRADEX Ophthalmic Suspension and Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension in the treatment of ocular inflammation and infection associated with blepharaconjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05% | Experimental | Tobramycin 0.3%/Dexamethasone 0.05% 1 drop 4 times daily in both eyes |
|
| TOBRADEX | Active Comparator | TOBRADEX 1 drop 4 times daily in both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobramycin 0.3%/Dexamethasone 0.05% | Drug | Tobramycin 0.3%/Dexamethasone 0.05% 1 drop in both eyes 4 times daily for at least 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) | Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria. | Day 4 - Test Of Cure (TOC) compared to Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Brubaker, BSN MPH | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston | Houston | Texas | 77090 | United States |
Parallel, 1:1 ratio; double-masked
20 enrolling sites (private ophthalmology clinical offices) with first subject enrolled 10/29/07 and last subject enrolled 2/14/08)
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| ID | Title | Description |
|---|---|---|
| FG000 | Tobramycin 0.3%/Dexamethasone 0.05% | Tobramycin 0.3%/Dexamethasone 0.05% |
| FG001 | TOBRADEX Ophthalmic Suspension | TOBRADEX Ophthalmic Suspension |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tobramycin 0.3%/Dexamethasone 0.05% | Tobramycin 0.3%/Dexamethasone 0.05% |
| BG001 | TOBRADEX Ophthalmic Suspension | TOBRADEX Ophthalmic Suspension |
| 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 | Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4) | Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria. | Posted | Number | Percent of patients | Day 4 - Test Of Cure (TOC) compared to Day 0 |
|
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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 | Tobramycin 0.3%/Dexamethasone 0.05% | Tobramycin 0.3%/Dexamethasone 0.05% |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| D000078162 | Tobramycin, Dexamethasone Drug Combination |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
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| TOBRADEX | Drug | TOBRADEX 1 drop in both eyes 4 times daily for at least 3 days |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
TOBRADEX Ophthalmic Suspension
|
|
| 0 |
| 109 |
| 0 |
| 109 |
| EG001 | TOBRADEX Ophthalmic Suspension | TOBRADEX Ophthalmic Suspension | 0 | 112 | 0 | 112 |
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| Carbohydrates |
| D003907 | Dexamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |