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

NCT ID: NCT00824070

Last Updated: 2011-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract Extraction

Keywords

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Besifloxacin

Besifloxacin ophthalmic suspension

Group Type EXPERIMENTAL

Besifloxacin hydrochloride

Intervention Type DRUG

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

Moxifloxacin

Vigamox (moxifloxacin ophthalmic solution, 0.5%)

Group Type ACTIVE_COMPARATOR

moxifloxacin hydrochloride

Intervention Type DRUG

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

Gatifloxacin

Zymar (gatifloxacin ophthalmic solution, 0.3%)

Group Type ACTIVE_COMPARATOR

gatifloxacin

Intervention Type DRUG

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

Interventions

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Besifloxacin hydrochloride

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

Intervention Type DRUG

moxifloxacin hydrochloride

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

Intervention Type DRUG

gatifloxacin

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

Intervention Type DRUG

Other Intervention Names

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Besivance Vigamox Zymar

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Donnefeld

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Locations

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Ophthalmic Consultants of Long Island

Rockville Centre, New York, United States

Site Status

Countries

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United States

Other Identifiers

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575

Identifier Type: -

Identifier Source: org_study_id