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NCT Number: NCT00407589

Systemic Pharmacokinetics of BOL-303224-A

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cornerstone Eyecare

High Point, North Carolina, 27262, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: ISV-403, Besifloxacin

Primary outcomes

  1. 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

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

    Time frame: Througout the study

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Dec 5, 2006
Registry last updated
Dec 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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