A Study to Determine if 0.6% ISV-403 is Safe and Effective 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

PHASE3

Total Enrollment

957 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-11-30

Brief Summary

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Evaluation of the clinical and microbial efficacy of 0.6% ISV-403, compared to vehicle in the treatment of bacterial conjunctivitis.

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Detailed Description

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Conditions

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Acute 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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ISV-403

0.6% ISV-403 ophthalmic suspension

Group Type EXPERIMENTAL

ISV-403

Intervention Type DRUG

Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.

Vehicle

Vehicle of ISV-403 ophthalmic suspension

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.

Interventions

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ISV-403

Subjects with bacterial conjunctivitis were randomized to receive 0.6% ISV-403 eye drops three times a day (TID) for 5 days.

Intervention Type DRUG

Vehicle

Subjects with bacterial conjunctivitis were randomized to receive vehicle eye drops three times a day (TID) for 5 days.

Intervention Type DRUG

Other Intervention Names

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besifloxacin Besivance BOL-303224

Eligibility Criteria

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Inclusion Criteria

* Must have a diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge and redness in at least one eye.
* Females of childbearing potential must utilized reliable contraceptive methods and have a negative pregnancy test.

Exclusion Criteria

* Pregnant or nursing females.
* Known hypersensitivity to fluoroquinolones or to any of the study ingredients.
* Use of any antibiotic within 72 hours of treatment.
* Any disease or condition that could interfere with the safety and efficacy evaluations of the study medications.
* Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No