Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

December 7, 2011 updated by: Bausch & Lomb Incorporated

An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rockville Center, New York, United States, 11570
        • Ophthalmic Consultants of Long Island

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Besifloxacin
Besifloxacin ophthalmic suspension
Drug: Besifloxacin hydrochloride
Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Names:
  • Besivance
ACTIVE_COMPARATOR: Moxifloxacin
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Drug: moxifloxacin hydrochloride
Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Names:
  • Vigamox
ACTIVE_COMPARATOR: Gatifloxacin
Zymar (gatifloxacin ophthalmic solution, 0.3%)
Drug: gatifloxacin
Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Other Names:
  • Zymar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Aqueous Humor Drug Concentration.
Time Frame: Visit 2, 1-14 days following screening visit
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Principal Investigator: Eric Donnefeld, Ophthalmic Consultants of Long Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (ESTIMATE)

January 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

December 13, 2011

Last Update Submitted That Met QC Criteria

December 7, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 575

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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