Hyperemia
Conditions
Keywords
Ocular Redness
Brief summary
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.
Interventions
Sponsors
ORA, Inc.
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Levels | Day 1 (Visit 2) | Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline (Visit 1) | Visual acuity testing should be done with best correction at 10ft |
| Slit Lamp Biomicroscopy | Baseline (Visit 1) | 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. |
| Intraocular Pressure | Day 8 (Visit 5) | Intraocular Pressure measured at baseline Day 8 (Visit 5) |
| Hematology and Blood Chemistry Analysis | Baseline (Visit 1) | Blood samples will be collected for hematology and blood chemistry parameters at Baseline (Visit 1) |
| Urinalysis | Baseline (Visit 1) | Urine sample will be collected for urinalysis at Baseline (Visit 1) |
Countries
United States
Outcome results
None listed