Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety Following Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025% Used Four Times Daily in Healthy, Adult Subjects.

Conditions
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Hyperemia

Intervention / Treatment
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* Drug: Brimonidine tartrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have ocular health within normal limits. have blood (hematology, blood chemistry) and urine analysis within normal limits. have a body weight within 15% of ideal weight Exclusion Criteria: have known contraindications or sensitivity to the use of any of the investigational drug(s) or their components, or any other medications required by the protocol; have any active systemic or ocular disorder other than refractive disorder. have presence of any abnormality of the lids, ocular surface, or lacrimal duct system that in the Investigator's opinion could affect ophthalmic drop absorption. have a history of chronic alcohol consumption. consume alcohol and/or caffeine or xanthine containing products within 48 hours prior to dosing at Visit 1 or anticipated use during the study. have a history of tobacco, nicotine, or nicotine containing product use within the last year prior to Visit 2; have significant weight change (over 10 pounds) within the 60 days prior to Visit 2; have blood donation or equivalent blood loss of 450 ml or more, within 60 days prior to Visit 2; have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg); have intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brimonidine tartrate<br>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). | Drug: Brimonidine tartrate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular Redness