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| ID | Type | Description | Link |
|---|---|---|---|
| P08653 |
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The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AzaSite | Active Comparator |
| |
| Vigamox | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AzaSite (azithromycin ophthalmic solution) | Drug | One drop ophthalmic solution at Visit 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Haque, MD | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | AzaSite | |
| FG001 | Vigamox |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AzaSite | |
| BG001 | Vigamox | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Baseline measures for two subjects were not included in this analysis due to missing data on too many data points. Although the total number of baseline participants was 37, the actual number included in the analysis was 35 subjects, 18 subjects in the Azasite group and 17 in the Vigamox group. |
| 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 | Concentration of AzaSite and Vigamox in the Tear Fluid Across Six Time Points Ranging From 15 Minutes to 24 Hours Following Administration. | Per Protocol Population | Posted | Mean | Standard Deviation | µg/mL | 15 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours |
|
|
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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 | AzaSite |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Kuhn/ Director | Inspire Pharmaceuticals, Inc. | 919 941-9777 | kkuhn@inspirepharm.com |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D015817 | Eye Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Vigamox (moxifloxacin hydrochloride ophthalmic solution) |
| Drug |
One drop ophthalmic solution at Visit 2 |
|
Total of all reporting groups
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Vigamox | 0 | 18 | 0 | 18 |
PI cannot publish or discuss trial results until written communication is received from Inspire Pharmaceuticals, Inc.
| Organic Chemicals |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |