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To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension | Experimental |
| |
| AL-15469A 0.5% | Experimental |
| |
| AL-6515 0.3% | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension | Drug | Topical ocular dosed 3 times per day for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Clinical Cure rate | Day 3 | |
| End of therapy Clinical Cure rate | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained bulbar conjunctival injection | Day 3 | |
| Microbiological Success | Day 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| AL-15469A 0.5% | Drug | Topical ocular dosed 3 times per day for 3 days |
|
| AL-6515 0.3% | Drug | Topical ocular dosed 3 times per day for 3 days |
|
| Vehicle | Drug | Topical ocular dosed 3 times per day for 3 days |
|
| ID | Term |
|---|---|
| D003234 | Conjunctivitis, Bacterial |
| ID | Term |
|---|---|
| D015818 | Eye Infections, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015817 | Eye Infections |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
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