Systemic Pharmacokinetics of BOL-303224-A

Phase 1

Completed

• Conditions: Conjunctivitis, Bacterial
• Interventions: Drug: BOL-303224-A

• Registration Number: NCT00407589
• Lead Sponsor: Bausch & Lomb Incorporated

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 available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-12-01
• Study First Submitted QC: 2006-12-01
• Study First Posted: 2006-12-05
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-07
• Last Update Posted: 2011-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Assessment of systemic pharmacokinetics following a single dose and steady-state pharmacokinetics after multiple TID dosing	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 Outcome Measures

Name	Time	Method
Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection	Througout the study

Trial Locations

Locations (1)

Cornerstone Eyecare; 🇺🇸 High point, North Carolina, United States