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| Name | Class |
|---|---|
| Ophthalmic Research Associates, Inc. | INDUSTRY |
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The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-38583 0.01% | Experimental | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
|
| AL-38583 0.05% | Experimental | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
|
| AL-38583 0.2% | Experimental | AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks |
|
| AL-38583 Vehicle | Placebo Comparator | AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks |
|
| MAXIDEX | Active Comparator | Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-38583 ophthalmic solution | Drug |
| ||
| AL-38583 ophthalmic solution vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily diary ocular redness scores | 2 week period between Day 0 and Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michela Palmer | Alcon Research | Study Director |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
Inactive ingredients used as a placebo comparator |
|
| Dexamethasone ophthalmic suspension, 0.1% | Drug |
|
|
| D007154 |
| Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |