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Topical Treatment of Bacterial Conjunctivitis and Its Effect on Microbial Flora

NCT ID: NCT00312338

Last Updated: 2012-11-02

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

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-06-30

Brief Summary

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Topical Treatment of Bacterial Conjunctivitis and its Effect on Microbial Flora

Detailed Description

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Conditions

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Bacterial Conjunctivitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Study Groups

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Infected Patient treated with Vigamox

Conjunctivitis-Infected Patient receiving Vigamox 0.5% in both eyes three times daily for 7 days.

Group Type EXPERIMENTAL

VIGAMOX

Intervention Type DRUG

1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days

Healthy Subjects

Healthy Subjects receiving no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VIGAMOX

1 drop of VIGAMOX® ophthalmic solution 0.5% in both eyes TID for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients from 1 to 13 years of age that have diagnosis of bacterial conjunctivitis in either or both eyes (for \< 3 days duration) based on clinical observation; matched healthy controls

Exclusion Criteria

* Cannot have had bacterial conjunctivitis symptoms as reported by parent for \> 2 days
Minimum Eligible Age

1 Year

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts University

OTHER

Sponsor Role collaborator

Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven J. Lichtenstein, M.D.

Role: PRINCIPAL_INVESTIGATOR

Investigator / Contact

Locations

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Multiple Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CMS-05-11

Identifier Type: -

Identifier Source: org_study_id