An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% ((VIGAMOX®) Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate Moxifloxacin 0.5% relative to Ofloxacin 0.3% in the treatment of bacterial conjunctivitis in Chinese patients.

Official Title
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An Evaluation of the Safety and Efficacy of Moxifloxacin Ophthalmic Solution 0.5% Versus Ofloxacin Ophthalmic Solution 0.3% in the Treatment of Bacterial Conjunctivitis in Chinese Patients

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: Moxifloxacin ophthalmic solution, 0.5%
* Drug: Ofloxacin ophthalmic solution, 0.3%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chinese. Diagnosis of bacterial conjunctivitis based on clinical observation. Understand and sign the approved informed consent. Legally authorized representative can provide informed consent for patients less than 18 years old and/or incapable of understanding the informed consent. Willing to complete all required study procedures and visits. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Women who are pregnant, lactating, or planning a pregnancy. Only 1 sighted eye or vision not correctable to 0.6 logMAR or better in either eye. Planned contact lens wear during the course of the study. Signs and symptoms of bacterial conjunctivitis for longer than 4 days prior to Screening (Day 1). Suspected fungal, viral, or Acanthamoeba infection. Any systemic or ocular disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study. History of recent surgery. Presence of concomitant systemic viral infection. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 1 Year

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moxifloxacin<br>Moxifloxacin ophthalmic solution, 0.5%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 | Drug: Moxifloxacin ophthalmic solution, 0.5%<br> <br> * Other names: VIGAMOX®;|
| Active Comparator: Ofloxacin<br>Ofloxacin ophthalmic solution, 0.3%, 1 drop instilled 3 times per day (TID) in each eye for 7 days with a test-of-cure (TOC) at Day 9 | Drug: Ofloxacin ophthalmic solution, 0.3%<br> <br> * Other names: Tarivid® Eye Drops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Cure Rate | Ocular signs of bacterial conjunctivitis (bulbar conjunctival injection and conjunctival discharge/exudates) were rated by the investigator on a 4-point scale, with 0=normal/absent; 1=mild; 2=moderate, and 3=severe. Clinical cure rate is presented as the percentage of participants for which the sum of the numerical scores for the 2 cardinal ocular signs of bacterial conjunctivitis was 0 at Day 9 TOC/Exit Visit. | Day 9 | 
| Microbiological Success Rate | Microbiological specimen(s) from the affected eye(s) were collected according to a protocol-defined process. Microbiological success rate is presented as the percentage of participants for which the pre-therapy pathogens at Visit 1 (Day 1) were eradicated at Day 9 TOC/Exit Visit. | Day 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial conjunctivitis, Anti-infective, Antibiotics