Systemic Pharmacokinetics of BOL-303224-A

Completed · Phase 1

Conditions studied: Conjunctivitis, Bacterial

In brief

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.

Key facts

Study ID

NCT00407589

Run by

Bausch & Lomb Incorporated

People needed

24

Starts

2006-10-01

Expected to finish

2007-10-01

Last updated by the study team

2011-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cornerstone Eyecare — High Point, North Carolina, United States

Full record on ClinicalTrials.gov

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