Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-10-31

Brief Summary

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The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).

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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

Caregivers Investigators

Study Groups

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Besivance

Besifloxacin 0.6% ophthalmic suspension

Group Type EXPERIMENTAL

Besivance

Intervention Type DRUG

Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Gatifloxacin

Gatifloxacin 0.3% ophthalmic solution

Group Type ACTIVE_COMPARATOR

Gatifloxacin

Intervention Type DRUG

Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Interventions

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Besivance

Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

Intervention Type DRUG

Gatifloxacin

Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.

Exclusion Criteria

* Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.
* Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.
* Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.
* Subjects with systemic disease/disorder specified in the protocol as ineligible.
* Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.
* Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.

Minimum Eligible Age

1 Day

Maximum Eligible Age

31 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No