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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.
It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Other |
| |
| Brimonidine Tartrate 0.01% | Active Comparator |
| |
| Oxymetazoline HCl 0.025% | Active Comparator |
| |
| Brimonidine Tartrate 0.025% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle | Drug | one drop in each eye at designated visits |
| |
| Brimonidine Tartrate 0.01% |
| Measure | Description | Time Frame |
|---|---|---|
| Conjunctival Redness | at specified timepoints for up to 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ora, Inc. | Andover | Massachusetts | 01810 | United States |
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| Drug |
one drop in each eye at designated visits |
|
| Brimonidine Tartrate 0.025% | Drug | one drop in each eye at designated visits |
|
| Oxymetazoline HCl 0.025% | Drug | one drop in each eye at designated visits |
|
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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