A Study to Evaluate the Safety and Efficacy of Gatifloxacin for the Treatment of Bacterial Conjunctivitis

Study Overview
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Brief Summary
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This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of 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: gatifloxacin
* Drug: moxifloxacin 0.5% eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with bacterial conjunctivitis Exclusion Criteria: chemical or foreign body trauma to either eye infection in either eye (besides bacterial conjunctivitis) white spots in the cornea or ulcers in either eye clinical diagnosis of chlamydia or gonorrhea in either eye

Ages Eligible for Study
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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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: gatifloxacin<br>* Day 1-6 = 1 drop of study medication three times a day<br>* Other names: Zymar®;|
| Active Comparator: 2<br> | Drug: gatifloxacin<br>* Day 1-6 = 1 drop of study medication three times a day<br>* Other names: Zymar®;Drug: moxifloxacin 0.5% eye drops<br>* Day 1-6 = 1 drop of study medication three times a day<br>* Other names: Vigamox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Erythema and Conjunctival Discharge at Day 7 | Percentage of patients that achieved clinical success, defined as a score of 0 for both conjunctival erythema and conjunctival discharge at Day 7. Conjunctival erythema and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Microbiological Improvement | Percentage of patients with microbiological improvement, defined such that all bacteria present above threshold at Day 1 (Baseline) are eradicated (absent) or reduced at Day 7 based on a Classification of Microbial Response (Eradication=pathogen is absent in follow-up culture; Reduction=pathogen is reduced from baseline below threshold count in follow-up culture; Persistence=pathogen reduced from baseline but is above or equal to threshold count in follow-up culture; and Proliferation=pathogen has increased in count from baseline in follow-up culture). | Day 7 | 
| Percentage of Patients With Improvement in Ocular Signs for Lid Erythema | Percentage of patients with at least a 1-grade improvement in ocular signs for lid erythema at Day 7 from Day 1 (Baseline). Lid erythema was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). | Days 7 | 
| Percentage of Patients With Improvement in Ocular Signs for Conjunctival Discharge at Day 7 | Percentage of patients with at least a 1-grade improvement in ocular signs for conjunctival discharge at Day 7 from Day 1 (Baseline). Conjunctival discharge was assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). | Day 7 |