Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
Primary Purpose
Hyperemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Brimonidine tartrate
Sponsored by
About this trial
This is an interventional screening trial for Hyperemia focused on measuring Ocular Redness
Eligibility Criteria
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.
Sites / Locations
- Bausch & Lomb, Incorporated
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brimonidine tartrate
Arm Description
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).
Outcomes
Primary Outcome Measures
Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.
Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 2.
Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 7.
Plasma Levels
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.
Secondary Outcome Measures
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
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.
Intraocular Pressure
Intraocular Pressure measured at baseline Day 8 (Visit 5)
Hematology and Blood Chemistry Analysis
Blood samples will be collected for hematology and blood chemistry parameters at Baseline (Visit 1)
Urinalysis
Urine sample will be collected for urinalysis at Baseline (Visit 1)
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
Visual Acuity
Visual acuity testing should be done with best correction at 10ft
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.
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.
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.
Intraocular Pressure
Intraocular Pressure measured at baseline (Visit 1)
Hematology and Blood Chemistry Analysis
Blood samples will be collected for hematology and blood chemistry parameters at Day 8 (Visit 5)
Urinalysis
Urine sample will be collected for urinalysis at Day 8 (Visit 5)
Full Information
NCT ID
NCT02039765
First Posted
January 16, 2014
Last Updated
April 27, 2017
Sponsor
Bausch & Lomb Incorporated
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02039765
Brief Title
Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
Collaborators
ORA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperemia
Keywords
Ocular Redness
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brimonidine tartrate
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Brimonidine tartrate
Primary Outcome Measure Information:
Title
Plasma Levels
Description
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.
Time Frame
Day 1 (Visit 2)
Title
Plasma Levels
Description
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 2.
Time Frame
Day 2 (Visit 3)
Title
Plasma Levels
Description
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 7.
Time Frame
Day 7 (Visit 4)
Title
Plasma Levels
Description
Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.
Time Frame
Day 8 (Visit 5)
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
Visual acuity testing should be done with best correction at 10ft
Time Frame
Baseline (Visit 1)
Title
Slit Lamp Biomicroscopy
Description
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.
Time Frame
Baseline (Visit 1)
Title
Intraocular Pressure
Description
Intraocular Pressure measured at baseline Day 8 (Visit 5)
Time Frame
Day 8 (Visit 5)
Title
Hematology and Blood Chemistry Analysis
Description
Blood samples will be collected for hematology and blood chemistry parameters at Baseline (Visit 1)
Time Frame
Baseline (Visit 1)
Title
Urinalysis
Description
Urine sample will be collected for urinalysis at Baseline (Visit 1)
Time Frame
Baseline (Visit 1)
Title
Visual Acuity
Description
Visual acuity testing should be done with best correction at 10ft
Time Frame
Day 1 (Visit 2)
Title
Visual Acuity
Description
Visual acuity testing should be done with best correction at 10ft
Time Frame
Day 7 (Visit 4)
Title
Visual Acuity
Description
Visual acuity testing should be done with best correction at 10ft
Time Frame
Day 8 (Visit 5)
Title
Slit Lamp Biomicroscopy
Description
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.
Time Frame
Day 1 (Visit 2)
Title
Slit Lamp Biomicroscopy
Description
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.
Time Frame
Day 7 (Visit 4)
Title
Slit Lamp Biomicroscopy
Description
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.
Time Frame
Day 8 (Visit 5)
Title
Intraocular Pressure
Description
Intraocular Pressure measured at baseline (Visit 1)
Time Frame
Baseline (Visit 1)
Title
Hematology and Blood Chemistry Analysis
Description
Blood samples will be collected for hematology and blood chemistry parameters at Day 8 (Visit 5)
Time Frame
Day 8 (Visit 5)
Title
Urinalysis
Description
Urine sample will be collected for urinalysis at Day 8 (Visit 5)
Time Frame
Day 8 (Visit 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Ciolino, MD
Organizational Affiliation
ORA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb, Incorporated
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
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