Systemic Pharmacokinetics of BOL-303224-A
Primary Purpose
Conjunctivitis, Bacterial
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BOL-303224-A
Sponsored by
About this trial
This is an interventional treatment trial for Conjunctivitis, Bacterial
Eligibility Criteria
Inclusion Criteria:
- must be at least 18 years of age, any race
- must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes
- women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test
Exclusion Criteria:
- Pregnant or nursing women
- known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication
- use of any antibiotic within 72 hours of enrollment
- participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study
Sites / Locations
- Cornerstone Eyecare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BOL-303224-A
Arm Description
Systemic exposure of BOL-303224-A following single and multiple topical doses
Outcomes
Primary Outcome Measures
Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
Secondary Outcome Measures
Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection
Full Information
NCT ID
NCT00407589
First Posted
December 1, 2006
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00407589
Brief Title
Systemic Pharmacokinetics of BOL-303224-A
Official Title
Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multi-center, open-label, single dose/multiple dose, pharmacokinetic study in participants with bacterial conjunctivitis. The purpose of this study is to determine the extent of systemic exposure to BOL-303224-A following single and multiple topical administration of BOL-303224-A in participants with suspected bacterial conjunctivitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Bacterial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BOL-303224-A
Arm Type
Experimental
Arm Description
Systemic exposure of BOL-303224-A following single and multiple topical doses
Intervention Type
Drug
Intervention Name(s)
BOL-303224-A
Other Intervention Name(s)
ISV-403, Besifloxacin
Intervention Description
1 drop in each eye, TID for 5 days at approximately 6 h intervals, with a final, single dose on the morning of Visit 7 (Day 6).
Primary Outcome Measure Information:
Title
Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing
Time Frame
Blood samples will be collected from 0 to 6 hours on Day 1 and from 0 to 12 hours on Day 6. There will be additional sampling times at 0 hours on Day 2-5.
Secondary Outcome Measure Information:
Title
Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection
Time Frame
Througout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
must be at least 18 years of age, any race
must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in both eyes
women of childbearing potential must utilize reliable contraceptive methods and have a negative pregnancy test
Exclusion Criteria:
Pregnant or nursing women
known hypersensitivity to fluoroquinolones or to any of the ingredients in the study medication
use of any antibiotic within 72 hours of enrollment
participation in an ophthalmic drug or devise research study within 30 days prior to entry in this study
Facility Information:
Facility Name
Cornerstone Eyecare
City
High point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Systemic Pharmacokinetics of BOL-303224-A
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