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To evaluate the Tobramycin tear concentration values of TOBRADEX® Ophthalmic Suspension, Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension versus TOBREX® Ophthalmic Solution in normal volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | Experimental | Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension |
|
| TOBREX® Ophthalmic Solution | Active Comparator | TOBREX® Ophthalmic Solution |
|
| TOBRADEX® Ophthalmic Suspension | Active Comparator | TOBRADEX® Ophthalmic Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOBRADEX Ophthalmic Suspension | Drug | TOBRADEX Ophthalmic Suspension 1 drop each eye at baseline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tobramycin Tear Concentration Cmax (Maximum Concentration) | Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period. | 2, 4, 6, 12, and 18 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Tobramycin Tear Concentration Area Under the Curve (AUC) | Trapezoidal AUC was calculated from 2 to 18 minutes. | 2 to 18 minutes post administration |
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Inclusion:
Exclusion
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
Treatment randomization schedules were generated and maintained by the Alcon SAS Programming group. Only when the data were verified and validated and the database locked were the appropriate personnel unmasked.
Randomized, single center (Alcon Eye Clinic),
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| ID | Title | Description |
|---|---|---|
| FG000 | TOBRADEX, Then Tob 0.3%/Dex 0.05%, Then TOBREX | Patients received TOBRADEX first, then Tob 0.3%/Dex 0.05%, then TOBREX |
| FG001 | Tob 0.3%/Dex 0.05%, Then TOBREX, Then TOBRADEX | Patients received Tob 0.3%/Dex 0.05% first, then TOBREX, then TOBRADEX |
| FG002 | TOBREX, Then TOBRADEX, Then Tob 0.3%/Dex 0.05% | Patients received TOBREX first, then TOBRADEX, then Tob 0.3%/Dex 0.05% |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Overall Study |
| 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 | Tobramycin Tear Concentration Cmax (Maximum Concentration) | Tear samples were collected to measure tobramycin concentrations at 2, 4, 6, 12, and 18 minutes post-drop instillation in each subject's right eye for each treatment period. | Posted | Mean | Standard Deviation | µg/mL | 2, 4, 6, 12, and 18 minutes |
|
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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% Ophthalmic Suspension | Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eye | Eye disorders | Systematic Assessment |
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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 |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014031 | Tobramycin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 |
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| Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension | Drug | Tobramycin 0.3% / Dexamethasone 0.05% Ophthalmic Suspension 1 drop each eye at baseline |
|
| TOBREX Ophthalmic Solution | Drug | TOBREX Ophthalmic Solution 1 drop each eye at baseline |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
TOBRADEX® Ophthalmic Suspension |
|
|
| Secondary | Tobramycin Tear Concentration Area Under the Curve (AUC) | Trapezoidal AUC was calculated from 2 to 18 minutes. | Posted | Mean | Standard Deviation | min*ug/mL | 2 to 18 minutes post administration |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | TOBREX® | TOBREX® Ophthalmic Solution | 0 | 21 | 0 | 21 |
| EG002 | TOBRADEX® | TOBRADEX® Ophthalmic Suspension | 0 | 21 | 2 | 21 |
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| Carbohydrates |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |