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This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOL-303224-A | Experimental | Systemic exposure of BOL-303224-A following single and multiple topical doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOL-303224-A | Drug | 1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing | Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection | Througout the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cornerstone Eyecare | High Point | North Carolina | 27262 | United States |
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| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C522124 | besifloxacin |
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| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |