Concentration of Besifloxacin, Gatifloxacin, and Moxiflox... | NCT00905762

Studies
Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation

NCT00905762

Sponsor

Bausch & Lomb Incorporated

Status

Completed

Last Update Posted

Dec 9, 2011Estimated

Enrollment

119Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Gatifloxacin
Moxifloxacin
Besifloxacin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Apr 2009Actual

Completion Date

Apr 2009Actual

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

May 20, 2009

First Posted Date

May 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2011

Last Update Posted Date

Dec 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the concentration of besifloxacin compared to gatifloxacin and moxifloxacin in human conjunctival tissue, following a single drop of the drug instilled topically into the study eye. Conjunctival biopsies will be performed at specified time points, followed by the use of loteprednol etabonate/tobramycin ophthalmic suspension four times a day for 5 days.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

119Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Besifloxacin	Experimental	Besifloxacin one drop instilled into study eye.	Drug: Besifloxacin
Gatifloxacin	Active Comparator	Gatifloxacin one drop instilled into study eye.	Drug: Gatifloxacin
Moxifloxacin	Active Comparator	Moxifloxacin one drop instilled into study eye.	Drug: Moxifloxacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gatifloxacin	Drug	Gatifloxacin 0.3% one drop instilled into study eye at visit 2.	Gatifloxacin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.		Biopsies collected at specified time points from 15 minutes to 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Visual acuity		Day -14 through Day 6(+/-1)
Slit Lamp Biomicroscopy		Day -14 through Day 6 (+/-)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing to avoid all disallowed medications for the appropriate washout periods.
Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart.

Exclusion Criteria:

Have a known allergy and/or sensitivity to the test articles or its components or any therapy associated with the trial.
Monocular.
Have previously participated in a conjunctival biopsy study.
Be currently enrolled in an investigational drug or device study or have uses of an investigational drug or device within 30 days of entry into this study.
have a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Timothy Comstock, OD	Bausch & Lomb Incorporated	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bausch & Lomb Incorporated		Rochester	New York	14609	United States

Intervention Browse Module

MeSH Terms

ID	Term
D000077734	Gatifloxacin
D000077266	Moxifloxacin
C522124	besifloxacin

Ancestor Terms

ID	Term
D024841	Fluoroquinolones
D042462	4-Quinolones
D015363	Quinolones
D011804	Quinolines

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Browse Branches

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