Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-02-28

Brief Summary

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This study is being conducted to evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension compared with vehicle in the treatment of bacterial conjunctivitis. This study was conducted as a phase IIb study and continued with further enrollment as a phase III study.

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Detailed Description

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Conditions

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Bacterial Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Besifloxacin

0.6% ophthalmic suspension

Group Type EXPERIMENTAL

Besifloxacin

Intervention Type DRUG

Besifloxacin 0.6% administered into the study eye two times a day for three days.

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle (Placebo)

Intervention Type DRUG

Vehicle administered to the study eye two times a day for three days.

Interventions

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Besifloxacin

Besifloxacin 0.6% administered into the study eye two times a day for three days.

Intervention Type DRUG

Vehicle (Placebo)

Vehicle administered to the study eye two times a day for three days.

Intervention Type DRUG

Other Intervention Names

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Besivance

Eligibility Criteria

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Inclusion Criteria

* Subjects who are at least one year of age.
* Subjects who have a clinical diagnosis of acute bacterial conjunctivitis.
* Subjects who are willing to discontinue contact lens wear for the duration of the study.

Exclusion Criteria

* Subjects who have any uncontrolled systemic disease or debilitating disease.
* Subjects with known sensitivity or contraindications to besifloxacin, fluoroquinolones or any ingredients in study drugs.
* Subjects who are expected to require treatment with any disallowed medications.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No