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| ID | Type | Description | Link |
|---|---|---|---|
| P08654 |
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The purpose of this study is to evaluate the drug concentrations of AzaSite™ compared to Vigamox at various time points in conjunctiva tissue of healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin-30 minutes Post dose | Experimental |
| |
| Azithromycin-2 hours post dose | Experimental |
| |
| Azithromycin-12 hours post dose | Experimental |
| |
| Azithromycin-24 hours post dose | Experimental |
| |
| Moxifloxacin-30 minutes post dose | Experimental |
| |
| Moxifloxacin-2 hours post dose | Experimental |
| |
| Moxifloxacin-12 hours post dose | Experimental |
| |
| Moxafloxacin-24 hours post dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | azithromycin topical solution 1% given as a single drop in a single eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Pharmacokinetic Parameters | Up to 24 hours | |
| Assessment of Pharmacokinetic Parameters | Conjunctiva Concentration of Azithromycin and Moxifloxacin | Over 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Haque | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19108788 | Derived | Torkildsen G, O'Brien TP. Conjunctival tissue pharmacokinetic properties of topical azithromycin 1% and moxifloxacin 0.5% ophthalmic solutions: a single-dose, randomized, open-label, active-controlled trial in healthy adult volunteers. Clin Ther. 2008 Nov;30(11):2005-14. doi: 10.1016/j.clinthera.2008.10.020. |
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Normal volunteers
December 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose | |
| FG001 | Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose | |
| FG002 | Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose | |
| FG003 | Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose | |
| FG004 | Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose | |
| FG005 | Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose | |
| FG006 | Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose | |
| FG007 | Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose | |
| BG001 | Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose | |
| BG002 | Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose |
| 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 | Assessment of Pharmacokinetic Parameters | Not Posted | Up to 24 hours | |||||||||||||
| Primary | Assessment of Pharmacokinetic Parameters | Conjunctiva Concentration of Azithromycin and Moxifloxacin | Posted | Mean | Standard Deviation | μg/g | Over 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 | Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Haemorrhage | Vascular disorders | MedRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Inspire Pharmaceuticals, Inc. | 010-941-9777 | kkuhn@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 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Experimental |
|
|
| Moxifloxacin | Drug | Moxifloxacin topical solution given as a single drop in a single eye |
|
|
| BG003 | Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose |
| BG004 | Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose |
| BG005 | Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose |
| BG006 | Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose |
| BG007 | Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose | |
| OG001 | Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose | |
| OG002 | Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose | |
| OG003 | Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose | |
| OG004 | Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose | |
| OG005 | Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose | |
| OG006 | Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose | |
| OG007 | Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose |
|
|
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose | 0 | 6 | 1 | 6 |
| EG002 | Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose | 0 | 6 | 1 | 6 |
| EG003 | Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose | 0 | 6 | 0 | 6 |
| EG004 | Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose | 0 | 6 | 3 | 6 |
| EG005 | Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose | 0 | 6 | 2 | 6 |
| EG006 | Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose | 0 | 6 | 0 | 6 |
| EG007 | Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose | 0 | 6 | 1 | 6 |
| Eyelid Margin Crusting | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Eye Pain | Eye disorders | MedDRA (10.1) | Systematic Assessment |
|
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| Organic Chemicals |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |