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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
History of Changes
  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:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

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
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

ClinicalTrials.gov processed this record on May 23, 2013