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The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fusidic Acid 1% | Experimental | Participants will instill one drop of fusidic acid 1% per eye twice a day (BID) for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing |
|
| Placebo | Placebo Comparator | Participants will instill one drop of Placebo ophthalmic solution per eye BID for 7 days. Approximately 12 hours between doses is preferred, but BID administration takes precedence over precise timing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fusidic Acid 1% | Drug | Fusidic acid 1% |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure | Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure. | Visit 2 (Day 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial Eradication | Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication. | Visit 2 (Day 4) |
| Microbial Eradication | Proportion of subjects with a positive bacterial culture at Visit 1 (Day 1) who achieve microbiological eradication. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Contact | 4349808100 | info@baxis.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baxis Site 04 | Recruiting | Little Rock | Arkansas | 72205 | United States |
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All study staff (Sponsor, Site and Contract Research Organization (CRO)) involved in the day to day activities of the study are masked. Each site will have a designated unmasked dosing coordinator and the Sponsor/CRO will have an unmasked team member(s) as well, who is not involved in study conduct (e.g., for investigational product or statistical activities that require an unmasked individual).
| Drug |
Placebo ophthalmic solution |
|
| Visit 3 (Day 8) |
| Clinical Cure | Proportion of patients with a positive bacterial culture at Visit 1 (Day 1) who achieve clinical cure. | Visit 3 (Day 8) |
| Baxis Site 24 | Withdrawn | Huntington Beach | California | 92647 | United States |
| Baxis Site 19 | Recruiting | La Jolla | California | 92037 | United States |
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| Baxis Site 39 | Recruiting | Long Beach | California | 90813 | United States |
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| Baxis Site 31 | Recruiting | Los Angeles | California | 90020 | United States |
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| Baxis Site 38 | Recruiting | Los Angeles | California | 90048 | United States |
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| Baxis Site 20 | Terminated | Sherman Oaks | California | 91423 | United States |
| Baxis Site 34 | Recruiting | Delray Beach | Florida | 33484 | United States |
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| Baxis Site 22 | Terminated | Doral | Florida | 33172 | United States |
| Baxis Site 11 | Recruiting | Lake Worth | Florida | 33460 | United States |
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| Baxis Site 37 | Recruiting | Largo | Florida | 33773 | United States |
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| Baxis Site 27 | Recruiting | Lutz | Florida | 33549 | United States |
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| Baxis Site 01 | Recruiting | Miami | Florida | 33155 | United States |
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| Baxis Site 03 | Terminated | Miami | Florida | 33176 | United States |
| Baxis Site 13 | Terminated | Miami Beach | Florida | 33140 | United States |
| Baxis Site 28 | Recruiting | Miami Lakes | Florida | 33014 | United States |
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| Baxis Site 29 | Recruiting | Palm Springs | Florida | 33461 | United States |
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| Baxis Site 10 | Recruiting | Tampa | Florida | 33613 | United States |
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| Baxis Site 35 | Recruiting | Union City | Georgia | 30291 | United States |
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| Baxis Site 15 | Terminated | Idaho Falls | Idaho | 83404 | United States |
| Baxis Site 06 | Recruiting | Orland Park | Illinois | 60462 | United States |
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| Baxis Site 26 | Withdrawn | Columbia | Maryland | 21045 | United States |
| Baxis Site 21 | Terminated | North Las Vegas | Nevada | 89030 | United States |
| Baxis Site 23 | Withdrawn | Babylon | New York | 11702 | United States |
| Baxis Site 05 | Terminated | Mount Airy | North Carolina | 27030 | United States |
| Baxis Site 25 | Withdrawn | Tulsa | Oklahoma | 74133 | United States |
| Baxis Site 30 | Recruiting | Gresham | Oregon | 97030 | United States |
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| Baxis Site 09 | Withdrawn | Pittsburgh | Pennsylvania | 15227 | United States |
| Baxis Site 12 | Recruiting | Charleston | South Carolina | 29414 | United States |
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| Baxis Site 33 | Recruiting | Greenville | South Carolina | 29607 | United States |
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| Baxis Site 08 | Recruiting | Edinburg | Texas | 78539 | United States |
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| Baxis Site 02 | Terminated | Humble | Texas | 77338 | United States |
| Baxis Site 14 | Terminated | Kingwood | Texas | 77345 | United States |
| Baxis Site 36 | Recruiting | Mission | Texas | 78572 | United States |
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| Baxis Site 17 | Terminated | Layton | Utah | 84041 | United States |
| Baxis Site 18 | Terminated | Layton | Utah | 84041 | United States |
| Baxis Site 16 | Withdrawn | West Valley City | Utah | 84120 | United States |
| Baxis Site 32 | Recruiting | Charlottesville | Virginia | 22902 | United States |
|
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D007239 | Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
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