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Systemic Pharmacokinetics of BOL-303224-A

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00407589
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
12
Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis
Study Start Date :
Oct 1, 2006
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Oct 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: BOL-303224-A

Systemic exposure of BOL-303224-A following single and multiple topical doses

Drug: BOL-303224-A
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).
Other Names:
  • ISV-403
  • Besifloxacin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing [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 Measures

    1. Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection [Througout the study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cornerstone Eyecare High point North Carolina United States 27262

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT00407589
    Other Study ID Numbers:
    • 478-PK
    First Posted:
    Dec 5, 2006
    Last Update Posted:
    Dec 9, 2011
    Last Verified:
    Dec 1, 2011
    Additional relevant MeSH terms:
    Conjunctivitis, Bacterial
    Conjunctivitis
    Besifloxacin

    Study Results

    No Results Posted as of Dec 9, 2011