Systemic Pharmacokinetics of BOL-303224-A

NCT00407589 | Completed Phase 1

• 1 other identifier: 478-PK
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Conjunctivitis, Bacterial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Througout the study

Study Arms (1)

BOL-303224-A

EXPERIMENTAL

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

Drug: BOL-303224-A

Interventions

BOL-303224-A DRUG

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).

Also known as: ISV-403, Besifloxacin

BOL-303224-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Cornerstone Eyecare

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

besifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2006
• First Posted: December 5, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 9, 2011

Record last verified: 2011-12

Locations

US (1)