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

Tracking Information
First Received Date ^ICMJE	December 1, 2006
Last Updated Date	December 7, 2011
Start Date ^ICMJE	October 2006
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 25, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: December 1, 2006)	Plasma pharmacokinetic data will be calculated where possible, including plasma concentrations, Cmin, Cmax, Tmax and AUC.
Change History	Complete list of historical versions of study NCT00407589 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 25, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Systemic Pharmacokinetics of BOL-303224-A
Official Title ^ICMJE	Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Conjunctivitis, Bacterial
Intervention ^ICMJE	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
Study Arm (s)	Experimental: BOL-303224-A Systemic exposure of BOL-303224-A following single and multiple topical doses Intervention: Drug: BOL-303224-A
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	24
Completion Date	October 2007
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00407589
Other Study ID Numbers ^ICMJE	478-PK
Has Data Monitoring Committee	No
Responsible Party	Bausch & Lomb Incorporated
Study Sponsor ^ICMJE	Bausch & Lomb Incorporated
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bausch & Lomb Incorporated
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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