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

Primary Purpose

Cataract Extraction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Besifloxacin hydrochloride
moxifloxacin hydrochloride
gatifloxacin
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cataract Extraction focused on measuring Bioavailability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ophthalmic Consultants of Long Island

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Besifloxacin

Moxifloxacin

Gatifloxacin

Arm Description

Besifloxacin ophthalmic suspension

Vigamox (moxifloxacin ophthalmic solution, 0.5%)

Zymar (gatifloxacin ophthalmic solution, 0.3%)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 15, 2009
Last Updated
December 7, 2011
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00824070
Brief Title
Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Official Title
An Open-Label, Randomized Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects After a Single Topical Dose
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Extraction
Keywords
Bioavailability

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Besifloxacin
Arm Type
Experimental
Arm Description
Besifloxacin ophthalmic suspension
Arm Title
Moxifloxacin
Arm Type
Active Comparator
Arm Description
Vigamox (moxifloxacin ophthalmic solution, 0.5%)
Arm Title
Gatifloxacin
Arm Type
Active Comparator
Arm Description
Zymar (gatifloxacin ophthalmic solution, 0.3%)
Intervention Type
Drug
Intervention Name(s)
Besifloxacin hydrochloride
Other Intervention Name(s)
Besivance
Intervention Description
Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Intervention Type
Drug
Intervention Name(s)
moxifloxacin hydrochloride
Other Intervention Name(s)
Vigamox
Intervention Description
Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Intervention Type
Drug
Intervention Name(s)
gatifloxacin
Other Intervention Name(s)
Zymar
Intervention Description
Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Primary Outcome Measure Information:
Title
The Aqueous Humor Drug Concentration.
Description
An aqueous humor specimen was collected from the study eye for determination of drug concentration 60 min after study drug instillation.
Time Frame
Visit 2, 1-14 days following screening visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Donnefeld
Organizational Affiliation
Ophthalmic Consultants of Long Island
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Center
State/Province
New York
ZIP/Postal Code
11570
Country
United States

12. IPD Sharing Statement

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

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