Systemic Pharmacokinetics of BOL-303224-A

Bausch + Lomb

Status and phase: Completed; Phase 1

Conditions: Conjunctivitis, Bacterial

Treatments: Drug: BOL-303224-A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407589

478-PK

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

BOL-303224-A

Experimental group

Description:

Systemic exposure of BOL-303224-A following single and multiple topical doses

Treatment:

Drug: BOL-303224-A