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Systemic Pharmacokinetics of BOL-303224-A

NCT ID: NCT00407589

Last Updated: 2011-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-10-31

Brief Summary

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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

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Conditions

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Conjunctivitis, Bacterial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BOL-303224-A

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

Group Type EXPERIMENTAL

BOL-303224-A

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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ISV-403 Besifloxacin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cornerstone Eyecare

High Point, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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478-PK

Identifier Type: -

Identifier Source: org_study_id