Systemic Pharmacokinetics of BOL-303224-A

Conjunctivitis, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00407589
• Other study ID #: 478-PK
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2006
• Last updated: December 7, 2011
• Start date: October 2006
• Est. completion date: October 2007

Study information

• Verified date: December 2011
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Bacterial

Intervention

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).

Locations

Country	Name	City	State
United States	Cornerstone Eyecare	High point	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Investigator ratings of ocular discharge and bulbar conjunctival injection, Visual Acuity, ophthalmoscopy findings and Adverse event collection		Througout the study	No