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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 H

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 Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome:

• 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: Same as current

Current Secondary Outcome:

• 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: Same as current

Information By: Bausch & Lomb Incorporated

Dates:
Date Received: January 16, 2014
Date Started: February 2014
Date Completion:
Last Updated: April 27, 2017
Last Verified: April 2017