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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

Tracking Information
First Submitted Date  ICMJE January 16, 2014
First Posted Date  ICMJE January 20, 2014
Last Update Posted Date April 28, 2017
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02039765 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
  • Visual Acuity [ Time Frame: Baseline (Visit 1) ]
    Visual acuity testing should be done with best correction at 10ft
  • 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.
  • Intraocular Pressure [ Time Frame: Day 8 (Visit 5) ]
    Intraocular Pressure measured at baseline Day 8 (Visit 5)
  • 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)
  • Urinalysis [ Time Frame: Baseline (Visit 1) ]
    Urine sample will be collected for urinalysis at Baseline (Visit 1)
  • Visual Acuity [ Time Frame: Day 1 (Visit 2) ]
    Visual acuity testing should be done with best correction at 10ft
  • Visual Acuity [ Time Frame: Day 7 (Visit 4) ]
    Visual acuity testing should be done with best correction at 10ft
  • Visual Acuity [ Time Frame: Day 8 (Visit 5) ]
    Visual acuity testing should be done with best correction at 10ft
  • 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.
  • 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.
  • 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.
  • Intraocular Pressure [ Time Frame: Baseline (Visit 1) ]
    Intraocular Pressure measured at baseline (Visit 1)
  • 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)
  • Urinalysis [ Time Frame: Day 8 (Visit 5) ]
    Urine sample will be collected for urinalysis at Day 8 (Visit 5)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Safety of Topical Administration of Brimonidine Tartrate Ophthalmic Solution 0.025%.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Hyperemia
Intervention  ICMJE Drug: Brimonidine tartrate
Study Arms  ICMJE 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).
Intervention: Drug: Brimonidine tartrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2014)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2014)
15
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02039765
Other Study ID Numbers  ICMJE 863/13-100-0007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bausch & Lomb Incorporated
Study Sponsor  ICMJE Bausch & Lomb Incorporated
Collaborators  ICMJE ORA, Inc.
Investigators  ICMJE
Study Director: Joseph Ciolino, MD ORA, Inc.
PRS Account Bausch & Lomb Incorporated
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP