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Completed

NCT Number: NCT02039765

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

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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Key information

Conditions

Hyperemia Cardiovascular Diseases Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bausch & Lomb, Incorporated

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brimonidine Tartrate

Drug

Primary outcomes

  1. Plasma Levels

    Time frame: Day 1 (Visit 2)

    Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 1.

  2. Plasma Levels

    Time frame: Day 2 (Visit 3)

    Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 2.

  3. Plasma Levels

    Time frame: Day 7 (Visit 4)

    Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 7.

  4. Plasma Levels

    Time frame: Day 8 (Visit 5)

    Blood samples will be collected for the determination of brimonidine in plasma at the specified time points on Day 8.

Secondary outcomes

  1. Visual Acuity

    Time frame: Baseline (Visit 1)

    Visual acuity testing should be done with best correction at 10ft

  2. Slit Lamp Biomicroscopy

    Time frame: 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.

  3. Intraocular Pressure

    Time frame: Day 8 (Visit 5)

    Intraocular Pressure measured at baseline Day 8 (Visit 5)

  4. Hematology and Blood Chemistry Analysis

    Time frame: Baseline (Visit 1)

    Blood samples will be collected for hematology and blood chemistry parameters at Baseline (Visit 1)

  5. Urinalysis

    Time frame: Baseline (Visit 1)

    Urine sample will be collected for urinalysis at Baseline (Visit 1)

  6. Visual Acuity

    Time frame: Day 1 (Visit 2)

    Visual acuity testing should be done with best correction at 10ft

  7. Visual Acuity

    Time frame: Day 7 (Visit 4)

    Visual acuity testing should be done with best correction at 10ft

  8. Visual Acuity

    Time frame: Day 8 (Visit 5)

    Visual acuity testing should be done with best correction at 10ft

  9. Slit Lamp Biomicroscopy

    Time frame: Day 1 (Visit 2)

    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.

  10. Slit Lamp Biomicroscopy

    Time frame: Day 7 (Visit 4)

    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.

  11. Slit Lamp Biomicroscopy

    Time frame: Day 8 (Visit 5)

    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.

  12. Intraocular Pressure

    Time frame: Baseline (Visit 1)

    Intraocular Pressure measured at baseline (Visit 1)

  13. Hematology and Blood Chemistry Analysis

    Time frame: Day 8 (Visit 5)

    Blood samples will be collected for hematology and blood chemistry parameters at Day 8 (Visit 5)

  14. Urinalysis

    Time frame: Day 8 (Visit 5)

    Urine sample will be collected for urinalysis at Day 8 (Visit 5)

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2014
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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