A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis

Study Overview
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Brief Summary
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The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: Gatifloxacin 0.5% eye drops
* Drug: placebo eye drops


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically diagnosed with bacterial conjunctivitis Exclusion Criteria: Signs and/or symptoms of conjunctivitis for more than 96 hours Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis Clinical diagnosis of chlamydia in either eye

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gatifloxacin 0.5% Eye Drops<br>Gatifloxacin 0.5% Eye Drops | Drug: Gatifloxacin 0.5% eye drops<br>* Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily<br>|
| Placebo Comparator: Placebo Eye Drops<br>Placebo Eye Drops | Drug: placebo eye drops<br>* Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily<br>|

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 Hyperemia and Conjunctival Discharge Up to Day 6 | Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye up to Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). | 6 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6 | Percentage of patients that achieved clinical success, defined as achievement of a score of zero for both conjunctival hyperemia and conjunctival discharge in the study eye at Day 6. Conjunctival hyperemia and conjunctival discharge were each assessed on a 4-point severity grade scale (0=none, +1=mild, +2=moderate, +3=severe). | Day 6 | 
| Percentage of Patients With Microbiological Cure Up to Day 6 | Percentage of patients with microbiological cure, defined such that all bacteria present in the study eye at Day 1 (Baseline) are eradicated up to Day 6 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). | 6 Days | 
| Percentage of Patients With Clinical Improvement of Ocular Signs Up to Day 6 | Percentage of patients with clinical improvement of ocular signs up to Day 6 based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe), defined as a decrease (improvement) from Day 1 (Baseline) in the total score of conjunctival hyperemia and mucopurulent discharge (pus), with no increase (worsening) from Day 1 (Baseline) in either individual variable in the study eye. | 6 Days | 
| Percentage of Patients With Clinical Improvement of Ocular Symptoms Up to Day 6 | Percentage of patients with clinical improvement of ocular symptoms, defined as a decrease (improvement) up to Day 6 from Day 1 (Baseline) in the total score of itching and tearing (each on 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe), with no increase (worsening) from Day 1 (Baseline) in any individual score in the study eye diagnosed with bacterial conjunctivitis. | 6 Days |