Systemic Pharmacokinetics of BOL-303224-A

Systemic Pharmacokinetics of BOL-303224-A After Single and Multiple Instillations of BOL-303224-A in Subjects With Suspected Bacterial Conjunctivitis

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 Overview

• Status: Completed
• Conditions: Conjunctivitis, Bacterial
• Intervention / Treatment: Drug: BOL-303224-A

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • High point, North Carolina, United States, 27262
      • Cornerstone Eyecare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BOL-303224-A; Systemic exposure of BOL-303224-A following single and multiple topical doses	Drug: BOL-303224-A; 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).; Other Names: ISV-403; Besifloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: December 1, 2006
• First Submitted That Met QC Criteria: December 1, 2006
• First Posted (Estimate): December 5, 2006

Study Record Updates

• Last Update Posted (Estimate): December 9, 2011
• Last Update Submitted That Met QC Criteria: December 7, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Besifloxacin
• Other Study ID Numbers: 478-PK