Clinical Trial: Systemic Pharmacokinetics of BOL-303224-A

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome: 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. ]

Original Primary Outcome: Plasma pharmacokinetic data will be calculated where possible, including plasma concentrations, Cmin, Cmax, Tmax and AUC.

Current Secondary Outcome: Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection [ Time Frame: Througout the study ]

Original Secondary Outcome:

Information By: Bausch & Lomb Incorporated

Dates:
Date Received: December 1, 2006
Date Started: October 2006
Date Completion:
Last Updated: December 7, 2011
Last Verified: December 2011