NCT00824070

Brief Summary

This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or gatifloxacin in aqueous humor samples collected following topical instillation of the associated formulation in subjects undergoing cataract surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 29, 2010

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

5 months

First QC Date

January 15, 2009

Results QC Date

September 30, 2010

Last Update Submit

December 7, 2011

Conditions

Cataract Extraction

Keywords

Bioavailability

Outcome Measures

Primary Outcomes (1)

  • The Aqueous Humor Drug Concentration.

    An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.

    Visit 2, 1-14 days following screening visit

Study Arms (3)

Besifloxacin

EXPERIMENTAL

Besifloxacin ophthalmic suspension

Drug: Besifloxacin hydrochloride

Moxifloxacin

ACTIVE COMPARATOR

Vigamox (moxifloxacin ophthalmic solution, 0.5%)

Drug: moxifloxacin hydrochloride

Gatifloxacin

ACTIVE COMPARATOR

Zymar (gatifloxacin ophthalmic solution, 0.3%)

Drug: gatifloxacin

Interventions

Besifloxacin hydrochlorideDRUG

Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

Also known as: Besivance
Besifloxacin
moxifloxacin hydrochlorideDRUG

Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

Also known as: Vigamox
Moxifloxacin
gatifloxacinDRUG

Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.

Also known as: Zymar
Gatifloxacin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who are a candidate for a routine, uncomplicated, primary cataract extraction.
  • Subjects who, in the Investigator's opinion, have potential for postoperative best corrected Snellen visual acuity of at least 20/200 in the study eye.

You may not qualify if:

  • Subjects who have a known sensitivity, contraindication, or allergy to the study medication(s) or their components.
  • Subjects who had any corneal refractive surgery in the study eye.
  • Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
  • Subjects who had ocular surgery in the study eye, including laser procedures, within the past 6 months.
  • Subjects who have taken any topical ocular medication in the study eye, other than those required by the protocol and permitted for surgery, during the 24 hours prior to the study medication being instilled.
  • Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior to the surgery date.
  • Subjects who are monocular.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

MeSH Terms

Interventions

besifloxacinMoxifloxacinGatifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

All drug concentrations were significantly below MIC90 values for relevant staphylococcal species.

Results Point of Contact

Title
Tuyen Ong, MD
Organization
Bausch & Lomb Inc
tuyen.ong@bausch.com
(973) 360-6389

Study Officials

  • Eric Donnefeld

    Ophthalmic Consultants of Long Island

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

December 13, 2011

Results First Posted

October 29, 2010

Record last verified: 2011-12

Locations

US(1)