Moxifloxacin AF Ophthalmic Solution for Treatment of Bacterial Conjunctivitis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Moxifloxacin AF Ophthalmic Solution compared to Moxifloxacin AF Vehicle in the treatment of bacterial conjunctivitis in patients one month of age or older.

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%
* Other: Moxifloxacin AF Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with bacterial conjunctivitis in 1 or both eyes; Able to understand and sign an informed consent form. If subject is <18 years of age, the informed consent must be understood and signed by the subject's legally authorized representative; Agrees to comply with the visit schedule and other requirements of the study; Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Day 1; Presence of concomitant viral infection; Infants with ophthalmia neonatorum of gonococcal, Chlamydia, herpetic or chemical origin; Infants whose birth mothers had any sexually transmitted disease within 1 month prior to delivery; Infants undergoing treatment for retinopathy of prematurity; Contact lens wear during the course of the study; Only 1 sighted eye or vision in either eye not correctable to 0.6 logMAR units (20/80) or better; Use of medications, as specified in the protocol; Any systemic or ocular disease or disorder, complicating factors or structural abnormality that could negatively affect the conduct or outcome of the study; Known or suspected allergy or hypersensitivity to fluoroquinolones; Pregnant, lactating, or of childbearing potential and not using adequate birth control to prevent pregnancy; Other protocol-specified exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 1 Month

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin AF<br>Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%, 1 drop in each eye twice daily for 3 days | Drug: Moxifloxacin Alternative Formulation (AF) Ophthalmic Solution 0.5%<br>* Eye drops<br>|
| Placebo Comparator: Vehicle<br>Moxifloxacin AF vehicle, 1 drop in each eye twice daily for 3 days | Other: Moxifloxacin AF Vehicle<br>* Inactive ingredients used as a placebo for masking purposes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure at the Day 4 (EOT)/Exit Visit | Clinical cure was attained if the sum of the 2 cardinal ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudate) was zero (ie, normal or absent) 12-48 hours after the last dose. Clinical cure was reported as a percentage. Only one eye (study eye) contributed to the analysis. | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological Success at the Day 4 (EOT)/Exit Visit | Microbiological success was attained if the pre-therapy bacterial pathogens were eradicated 12-48 hours after the last dose. Microbiological success is reported as a percentage. Only one eye (study eye) contributed to the analysis. | Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pink eye, conjunctivitis, moxifloxacin, fluoroquinolone