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

Hyperemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039765
• Other study ID #: 863/13-100-0007
• Status: Completed
• Phase: Phase 1
• First received: January 16, 2014
• Last updated: April 27, 2017
• Start date: February 2014
• Est. completion date: April 2014

Study information

• Verified date: April 2017
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperemia

Intervention

Drug:
• Brimonidine tartrate

Locations

Country	Name	City	State
United States	Bausch & Lomb, Incorporated	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	Visual Acuity	Visual acuity testing should be done with best correction at 10ft	Baseline (Visit 1)
Secondary	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)
Secondary	Intraocular Pressure	Intraocular Pressure measured at baseline Day 8 (Visit 5)	Day 8 (Visit 5)
Secondary	Hematology and Blood Chemistry Analysis	Blood samples will be collected for hematology and blood chemistry parameters at Baseline (Visit 1)	Baseline (Visit 1)
Secondary	Urinalysis	Urine sample will be collected for urinalysis at Baseline (Visit 1)	Baseline (Visit 1)
Secondary	Visual Acuity	Visual acuity testing should be done with best correction at 10ft	Day 1 (Visit 2)
Secondary	Visual Acuity	Visual acuity testing should be done with best correction at 10ft	Day 7 (Visit 4)
Secondary	Visual Acuity	Visual acuity testing should be done with best correction at 10ft	Day 8 (Visit 5)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Intraocular Pressure	Intraocular Pressure measured at baseline (Visit 1)	Baseline (Visit 1)
Secondary	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)
Secondary	Urinalysis	Urine sample will be collected for urinalysis at Day 8 (Visit 5)	Day 8 (Visit 5)