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| ID | Type | Description | Link |
|---|---|---|---|
| C-01-401-004 |
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The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AzaSite | Experimental | 1.0% azithromycin in DuraSite |
|
| Tobramycin | Active Comparator | 0.3% tobramycin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AzaSite | Drug | AzaSite ophthalmic solution; one topical drop to the infected eye or eyes twice daily (in the morning and at bedtime) on Days 1 and 2 followed by once daily (in the morning between 7 and 10am) on Days 3 through 5. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Clinical Resolution at Visit 3 | Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection). | Visit 3 (Day 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Bacterial Eradication at Visit 3 | Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s). | Visit 3 (Day 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renaissance Center | Birmingham | Alabama | 35205 | United States | ||
| Children's Eye Physicians |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17652708 | Derived | Protzko E, Bowman L, Abelson M, Shapiro A; AzaSite Clinical Study Group. Phase 3 safety comparisons for 1.0% azithromycin in polymeric mucoadhesive eye drops versus 0.3% tobramycin eye drops for bacterial conjunctivitis. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3425-9. doi: 10.1167/iovs.06-1413. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AzaSite | |
| FG001 | Tobramycin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Tobramycin | Drug | Tobramycin ophthalmic solution; one topical drop to the infected eye or eyes four times daily at 4 to 6 hour intervals (first dose in the morning between 7 and 10am) for 5 days. |
|
| Littleton |
| Colorado |
| 80122 |
| United States |
| Palm Beach Eye Associates | Atlantis | Florida | 33462 | United States |
| The Eye Associates | Bradenton | Florida | 34209 | United States |
| Alan Shuster, MD | Jupiter | Florida | 33458 | United States |
| Pasco Eye Institute | New Port Richey | Florida | 34652 | United States |
| Tukoi Institute for Clinical Research | North Miami Beach | Florida | 33169 | United States |
| Advanced Eye Care | Panama City | Florida | 32405 | United States |
| Presidential Eye Center | West Palm Beach | Florida | 33401 | United States |
| Jon Fishburn, MD | Boise | Idaho | 83706 | United States |
| Medisphere Medical Research Center, LLC | Evansville | Indiana | 47714 | United States |
| Hutchinson Clinic | Hutchinson | Kansas | 67502 | United States |
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
| Mason Eye Institute | Columbia | Missouri | 65212 | United States |
| Ophthalmology Associates | Creve Coeur | Missouri | 63141 | United States |
| Research Eye Care Center | Kansas City | Missouri | 64132 | United States |
| Ophthalmology Associates | Princeton | New Jersey | 08540 | United States |
| Huntington Medical Group | Huntington Station | New York | 11746 | United States |
| Cornerstone Eye Care | High Point | North Carolina | 27262 | United States |
| Eye Health Northwest | Portland | Oregon | 97209 | United States |
| Irving Weinberger, MD | Pittsburgh | Pennsylvania | 15228 | United States |
| Southern Eye Associates, PA | Greenville | South Carolina | 29605 | United States |
| Corona Research Consultants, Inc. | El Paso | Texas | 79904 | United States |
| Cottonwood Ophthalmology Associates | Murray | Utah | 84107 | United States |
| Rockwood Clinic, PS-Eye Center | Spokane | Washington | 99205 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AzaSite | Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward. |
| BG001 | Tobramycin | Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| 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 | Number of Participants Who Achieved Clinical Resolution at Visit 3 | Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection). | Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward. | Posted | Number | Participants | Visit 3 (Day 6) |
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| Secondary | Number of Participants Who Achieved Bacterial Eradication at Visit 3 | Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s). | Per protocol population (defined as all randomized subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward. | Posted | Number | Participants | Visit 3 (Day 6) |
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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 | 365 | 0 | 365 | |||
| EG001 | Tobramycin | 0 | 378 | 0 | 378 |
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Institution and Principal Investigator shall not publish, present or use any data or results arising out of the performance of this study for their own instruction, research or publication without the prior express written consent of Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Development Group Leader | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D003231 | Conjunctivitis |
| D015817 | Eye Infections |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Male |
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