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

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ClinicalTrials.gov Identifier: NCT02039765
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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.

Condition or disease Intervention/treatment Phase
Hyperemia Drug: Brimonidine tartrate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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.
Actual Study Start Date : February 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brimonidine tartrate
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



Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039765


Locations
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United States, New York
Bausch & Lomb, Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
ORA, Inc.
Investigators
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Study Director: Joseph Ciolino, MD ORA, Inc.

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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT02039765     History of Changes
Other Study ID Numbers: 863/13-100-0007
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Bausch & Lomb Incorporated:
Ocular Redness
Additional relevant MeSH terms:
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Brimonidine Tartrate
Hyperemia
Vascular Diseases
Cardiovascular Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs