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Study of Ocular Penetration of Topically Administered Fluoroquinolones

NCT ID: NCT00924729

Last Updated: 2017-10-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-11-30

Brief Summary

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This study is being conducted to evaluate the intraocular penetration of Moxifloxacin 0.5% ophthalmic solution (Vigamox) and Besifloxacin 0.6% ophthalmic suspension (Besivance) after pre-operative topical administration in subjects undergoing cataract surgery.

Detailed Description

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Conditions

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Cataract Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Moxifloxacin 0.5% ophthalmic solution

Group Type ACTIVE_COMPARATOR

Moxifloxacin 0.5% ophthalmic solution

Intervention Type DRUG

Administer moxifloxacin study drug prior to cataract surgery.

Besifloxacin 0.6% ophthalmic suspension

Group Type ACTIVE_COMPARATOR

Besifloxacin 0.6% ophthalmic suspension

Intervention Type DRUG

Administer besifloxacin study drug prior to cataract surgery.

Interventions

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Moxifloxacin 0.5% ophthalmic solution

Administer moxifloxacin study drug prior to cataract surgery.

Intervention Type DRUG

Besifloxacin 0.6% ophthalmic suspension

Administer besifloxacin study drug prior to cataract surgery.

Intervention Type DRUG

Other Intervention Names

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Vigamox Besivance

Eligibility Criteria

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Inclusion Criteria

* Subjects who have a visually significant cataract and are planning to have cataract surgery.
* Subjects who are willing/able and have signed informed consent approved by the Institutional Review Board.

Exclusion Criteria

* Subjects who have a known hypersensitivity, allergy, or contraindication to any fluoroquinolone medication, in any form.
* Subjects who signs of ocular infection or active inflammation in the study eye.
* Subjects who have corneal pathology, including epithelial defect, corneal scarring, or severe dry eye syndrome.
* Subjects who have used any disallowed medication (including antibiotics) during the time period designated as described in the protocol.
* Subjects who have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and is likely to increase the risk of infection to the patient or confound the results of the study.
* Subjects who are pregnant (or suspect to be pregnant) or nursing/lactating.
* Subjects who have participated in any study of an investigational drug or device within 30 days prior to enrollment.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walter J. Stark, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Wilmer Eye Institute

Locations

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The Wilmer Eye Institute at Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_28692

Identifier Type: -

Identifier Source: org_study_id