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A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms

NCT ID: NCT00874887

Last Updated: 2011-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-10-31

Brief Summary

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The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the study eye affects the development of resistant bacteria on the conjunctiva based upon changes in the surface flora over the course of 2 weeks of topical treatment in healthy adult subjects.

Detailed Description

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Conditions

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Anti-biotic Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Vigamox®

moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water

Group Type ACTIVE_COMPARATOR

moxifloxacin 0.5% HCI ophthalmic solution

Intervention Type DRUG

1 drop in study eye three times a day for 14 days

Zymar®

gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride

Group Type ACTIVE_COMPARATOR

gatifloxacin ophthalmic solution 0.3%

Intervention Type DRUG

1 drop in study eye four times a day for 14 days

Interventions

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moxifloxacin 0.5% HCI ophthalmic solution

1 drop in study eye three times a day for 14 days

Intervention Type DRUG

gatifloxacin ophthalmic solution 0.3%

1 drop in study eye four times a day for 14 days

Intervention Type DRUG

Other Intervention Names

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Vigamox® ZYMAR®

Eligibility Criteria

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Inclusion Criteria

* Male or Female
* At least 50 years of age
* In good general health

Exclusion Criteria

* Any ocular surgery or use of topical antibiotics or antiseptics in either eye within the last 3 months
* Use of topical steroids, or non-steroidal anti inflammatory drugs in either eye within 30 days of Baseline (or anticipated during the study)
* Use of lid scrubs within 7 days of Baseline in either eye (or anticipated use during the study)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Minneapolis, Minnesota, United States

Site Status

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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GMA-ZYM-08-001

Identifier Type: -

Identifier Source: org_study_id