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| ID | Type | Description | Link |
|---|---|---|---|
| C-01-401-003 |
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The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AzaSite | Experimental |
| |
| Vehicle | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AzaSite | Drug | 1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Achieved Clinical Resolution | Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection. | Visit 3 (Days 6-7) |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Achieved Bacteriological Eradication | Bacterial eradication is defined as the 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 6-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I Care! Eye Care! | Flagstaff | Arizona | 86001 | United States | ||
| Rx For Life, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18374301 | Derived | Abelson MB, Heller W, Shapiro AM, Si E, Hsu P, Bowman LM; AzaSite Clinical Study Group. Clinical cure of bacterial conjunctivitis with azithromycin 1%: vehicle-controlled, double-masked clinical trial. Am J Ophthalmol. 2008 Jun;145(6):959-65. doi: 10.1016/j.ajo.2008.01.019. Epub 2008 Mar 28. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AzaSite | |
| FG001 | Vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vehicle | Other | Vehicle contains sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. Vehicle was prescribed as a single topical drop to the infected eye(s) for 5 days, twice on the first two days (once in the morning and at bedtime) and once a day in the morning (between 7-10 AM) for the following three days. |
|
| Cudahy |
| California |
| 90201 |
| United States |
| North Bay Eye Associates | Petaluma and Santa Rosa | California | 95401 | United States |
| San Diego Eye and Laser Center | San Diego | California | 92123 | United States |
| Western States Clinical Research | Wheat Ridge | Colorado | 80033 | United States |
| Opticare Eye Health Center | Waterbury | Connecticut | 06708 | United States |
| International Eye Center | Tampa | Florida | 33603 | United States |
| Welborn Clinic and Welborn Clinic East | Evansville | Indiana | 47713 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Bossier Optical Inc. | Bossier City | Louisiana | 71111 | United States |
| Bohn and Joseph Eye Center | Lafayette | Louisiana | 70506 | United States |
| The Louisiana Eye Center | Zachary | Louisiana | 70791 | United States |
| Mississippi Eye Associates | Ocean Springs | Mississippi | 39564 | United States |
| Clinical Research Laboratories | Piscataway | New Jersey | 08854 | United States |
| Advanced Eyecare and Laser Center | Runnemede | New Jersey | 08078 | United States |
| Precision Eye Care | Huntington | New York | 11743 | United States |
| Charlotte Eye, Ear, Nose, and Throat | Charlotte | North Carolina | 28210 | United States |
| Horizon Eye Center | Charlotte | North Carolina | 28211 | United States |
| Groat Eyecare Associates | Greensboro | North Carolina | 27401 | United States |
| Abrams Eye Center | Cleveland | Ohio | 44115 | United States |
| Bend Memorial Clinic | Bend | Oregon | 97701 | United States |
| University Eye Surgeons | Maryville | Tennessee | 37803 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Eye Associates | Nashville | Tennessee | 37203 | United States |
| Metaclin Research, Inc. | Austin | Texas | 78704 | United States |
| Physicians Eye Associates & Cosmetic Laser | Houston | Texas | 77002 | United States |
| Marc Sanders, MD | Houston | Texas | 77030 | United States |
| Mark Mayo, MD | Pasadena | Texas | 77504 | United States |
| Sun Research Institute | San Antonio | Texas | 78205 | United States |
| Mountain View Eye Center | Layton | Utah | 84041 | United States |
| Cottonwood Eye and Laser Clinic | Salt Lake City | Utah | 84107 | United States |
| Advanced Healthcare, SC | Milwaukee | Wisconsin | 53209 | 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 participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment. |
| BG001 | Vehicle | Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment. |
| 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 | Participants Who Achieved Clinical Resolution | 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 participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward. | Posted | Number | Participants | Visit 3 (Days 6-7) |
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| Secondary | Participants Who Achieved Bacteriological Eradication | Bacterial eradication is defined as the 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 participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward. | Posted | Number | Participants | Visit 3 (Day 6-7) |
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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 | 333 | 0 | 333 | |||
| EG001 | Vehicle | 2 | 350 | 0 | 350 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cornela Ulcer | Eye disorders | MedDRA (7.0) |
| ||
| Cerebrovascular Accident | Nervous system disorders | MedDRA (7.0) |
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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 |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Male |
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