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

Study Overview
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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).

Official Title
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Evaluation of the Safety and Efficacy of Topical Besifloxacin Ophthalmic Suspension, 0.6% Compared With Gatifloxacin, 0.3% Ophthalmic Solution for the Treatment of Presumed Bacterial Conjunctivitis in Subjects From Birth to 31 Days of Age

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: Besivance
* Drug: Gatifloxacin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 31 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Besivance<br>Besifloxacin 0.6% ophthalmic suspension | Drug: Besivance<br>* Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days<br>|
| Active Comparator: Gatifloxacin<br>Gatifloxacin 0.3% ophthalmic solution | Drug: Gatifloxacin<br>* Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Resolution | Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia. | Visit 5 (Day 8+1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Resolution | Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia. | Visit 3 (Day 3) | 
| Microbial Eradication | Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline | Visit 5 (Day 8+1) | 
| Microbial Outcome | Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline: over all bacterial species over all and individual gram-positive bacterial species over all and individual gram-negative bacterial species | Visit 3 (Day 3) and Visit 5 (Day 8+1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular infections, bacterial