NCT00407589

CompletedPhase 1

Systemic Pharmacokinetics of BOL-303224-A

Bausch & Lomb Incorporated Source

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Other study identifiers

Sponsor study identifier

478-PK

Study Type

interventional

Actual enrollment (reported)

24

Locations

1 country

Sites

1

Timeline

Study Start

October 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2007

Actual (reported)

Study Completion

October 2007

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 24 participants
Study completion date: October 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
December 1, 2006
Actual (reported)
First Posted
December 5, 2006
Actual (reported)
Primary Completion
October 2007
Actual (reported)
Study Completion
October 2007
Actual (reported)

Last Updated: December 9, 2011
Status Verified: December 2011
Last Update Submitted: December 7, 2011

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-ADrug

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (1)

Cornerstone Eyecare

High Point, North Carolina, 27262, United States

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

besifloxacin

Condition Hierarchy (Ancestors)

Eye Infections, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsEye InfectionsConjunctivitisConjunctival DiseasesEye Diseases

Enrollment

24 participants (actual enrollment reported by the registry).

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 2006

Date type not reported

This date has not been verified as actual or estimated.

NCT01330355

Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

Phase 3Terminated

NCT01175590

Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle

Phase 3Completed

NCT00312338

Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

Phase 4Completed

NCT03235141

Local Pharmacokinetics of Azithromycin Eye Drops in Healthy Volunteers

Phase 1Unknown

NCT03698045

Safety and Tolerability of PRO-143 Ophthalmic Solution in Healthy Volunteers.

Phase 1Withdrawn

NCT01431170

Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children

Phase 1Completed

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

Contact the study team to confirm eligibility.

Primary Completion

October 2007

Actual (reported)

Study Completion

October 2007

Actual (reported)

Last Updated

December 9, 2011

Record last verified: 2011-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00407589
Data provider: ClinicalTrials.gov
Source updated: 2011-12-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:21 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

BOL-303224-A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations