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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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To characterize the plasma pharmacokinetics and safety profile of brimonidine following a single dose and 4 times per day (QID) dosing of brimonidine tartrate ophthalmic solution 0.025% for 7 days in healthy, adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brimonidine tartrate | Experimental | One drop of brimonidine tartrate ophthalmic solution 0.025% in each eye once at Visit 2 (Day 1) then four times daily (QID) approximately 4 hours apart at Visit 3 (Day 2) through day 6, and then once at Visit 4 (Day 7). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine tartrate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Levels | Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1. | Day 1 (Visit 2) |
| Plasma Levels | Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 2. | Day 2 (Visit 3) |
| Plasma Levels | Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 7. | Day 7 (Visit 4) |
| Plasma Levels | Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8. | Day 8 (Visit 5) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity testing should be done with best correction at 10ft | Baseline (Visit 1) |
| Slit Lamp Biomicroscopy | Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Ciolino, MD | ORA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Incorporated | Rochester | New York | 14609 | United States |
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| ID | Term |
|---|---|
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Baseline (Visit 1) |
| Intraocular Pressure | Intraocular Pressure measured at baseline Day 8 (Visit 5) | Day 8 (Visit 5) |
| Hematology and Blood Chemistry Analysis | Blood samples will be collected for hematology and blood chemistry parameters at Baseline (Visit 1) | Baseline (Visit 1) |
| Urinalysis | Urine sample will be collected for urinalysis at Baseline (Visit 1) | Baseline (Visit 1) |
| Visual Acuity | Visual acuity testing should be done with best correction at 10ft | Day 1 (Visit 2) |
| Visual Acuity | Visual acuity testing should be done with best correction at 10ft | Day 7 (Visit 4) |
| Visual Acuity | Visual acuity testing should be done with best correction at 10ft | Day 8 (Visit 5) |
| Slit Lamp Biomicroscopy | Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia. | Day 1 (Visit 2) |
| Slit Lamp Biomicroscopy | Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia. | Day 7 (Visit 4) |
| Slit Lamp Biomicroscopy | Lid and lid margin erythema and swelling, conjunctival erythema/hyperemia and chemosis will be graded on a scale of 0 - 4. with 0=normal and 4=marked. Half grade measurements will be accepted for erythema/hyperemia. | Day 8 (Visit 5) |
| Intraocular Pressure | Intraocular Pressure measured at baseline (Visit 1) | Baseline (Visit 1) |
| Hematology and Blood Chemistry Analysis | Blood samples will be collected for hematology and blood chemistry parameters at Day 8 (Visit 5) | Day 8 (Visit 5) |
| Urinalysis | Urine sample will be collected for urinalysis at Day 8 (Visit 5) | Day 8 (Visit 5) |