Systemic Pharmacokinetics of BOL-303224-A

Bausch & Lomb Incorporated24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Conjunctivitis, Bacterial

Interventions

BOL-303224-ADRUG

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cornerstone Eyecare

High Point, North Carolina, United States

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection

Time frame: Througout the study

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.