Systemic Pharmacokinetics of BOL-303224-A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00407589
First received: December 1, 2006
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Conjunctivitis, Bacterial
Drug: BOL-303224-A
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection [ Time Frame: Througout the study ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00407589

Locations
United States, North Carolina
Cornerstone Eyecare
High point, North Carolina, United States, 27262
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00407589     History of Changes
Other Study ID Numbers: 478-PK
Study First Received: December 1, 2006
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 26, 2014