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| ID | Type | Description | Link |
|---|---|---|---|
| P08655 |
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The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AzaSite Eye Drops | Active Comparator | One drop two times a day for two days and once a day for the next five days |
|
| Vigamox Eye Drops | Active Comparator | One drop three times a day for seven days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AzaSite Eye Drops | Drug | One drop two times a day for two days and once a day for the next five days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Nominal time is scheduled time relative to administration of the first eye drop | Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 |
| Measure | Description | Time Frame |
|---|---|---|
| Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 |
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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 |
|---|---|---|---|---|---|---|
| Cornea Consultants of Arizone | Phoenix | Arizona | 85032 | United States | ||
| Eye Care Arkansas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20813346 | Derived | Stewart WC, Crean CS, Zink RC, Brubaker K, Haque RM, Hwang DG. Pharmacokinetics of azithromycin and moxifloxacin in human conjunctiva and aqueous humor during and after the approved dosing regimens. Am J Ophthalmol. 2010 Nov;150(5):744-751.e2. doi: 10.1016/j.ajo.2010.05.039. Epub 2010 Sep 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azasite | |
| FG001 | Vigamox |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vigamox Eye Drops | Drug | One drop three times a day for seven days |
|
|
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| North Valley Eye Medical Group | Mission Hills | California | 91345 | United States |
| Center for Excellence in Eye Care | Miami | Florida | 33176 | United States |
| Eye Center of North Florida | Panama City | Florida | 32405 | United States |
| Coastal Research Associates, LLC | Atlanta | Georgia | 30339 | United States |
| Kentuckiana Institute for Eye Research | Louisville | Kentucky | 40207 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Ophthalmic Consultants of Long Island | Rockville Centre | New York | 11563 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29464 | United States |
| Glaucoma Consultants and Center for Eye Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Corona Research Consultants | El Paso | Texas | 79904 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Azasite | |
| BG001 | Vigamox | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Conjunctiva Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Nominal time is scheduled time relative to administration of the first eye drop | Posted | Mean | Standard Deviation | ug/g | Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 |
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| Secondary | Aqueous Humor Concentration Prior to Cataract Surgery at One of Ten Time Points Ranging From 1 to 14 Days (Per Protocol Pharmacokinetic Population) | Posted | Mean | Standard Deviation | ug/mL | Az(hr): 1,12,48,49,72,144,145,168,216,312; Vig(hr): 1,8,48,49,56,144,145,168,216,312 |
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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 | 0 | 58 | 3 | 58 | |||
| EG001 | Vigamox | 0 | 58 | 2 | 58 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraocular pressure increased | Investigations | MedDRA 11.0 |
|
PI cannot publish or discuss trial results until written communication is received from Inspire
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mike Schiewe | Inspire | 919-941-9777 | mschiewe@inspirepharm.com |
| 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 |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Male |
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| Timepoint 3 - 48 hrs (AzaSite and Vigamox) |
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| Timepoint 4 - 49 hrs (AzaSite and Vigamox) |
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| Timepoint 5 -72 hrs (AzaSite)/56 hrs (Vigamox) |
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| Timepoint 6 - 144 hrs (AzaSite and Vigamox) |
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| Timepoint 7 - 145 hrs (AzaSite and Vigamox) |
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| Timepoint 8 - 168 hrs (AzaSite and Vigamox) |
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| Timepoint 9 - 216 hrs (AzaSite and Vigamox) |
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| Timepoint 10 - 312 (AzaSite and Vigamox) |
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