A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms

Study Overview
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Brief Summary
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The purpose of this study is to assess if the presence of BAK in a fluoroquinolone in the study eye affects the development of resistant bacteria on the conjunctiva based upon changes in the surface flora over the course of 2 weeks of topical treatment in healthy adult subjects.

Conditions
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Anti-biotic Resistance

Intervention / Treatment
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* Drug: moxifloxacin 0.5% HCI ophthalmic solution
* Drug: gatifloxacin ophthalmic solution 0.3%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female At least 50 years of age In good general health Exclusion Criteria: Any ocular surgery or use of topical antibiotics or antiseptics in either eye within the last 3 months Use of topical steroids, or non-steroidal anti inflammatory drugs in either eye within 30 days of Baseline (or anticipated during the study) Use of lid scrubs within 7 days of Baseline in either eye (or anticipated use during the study)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vigamox®<br>moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water | Drug: moxifloxacin 0.5% HCI ophthalmic solution<br>* 1 drop in study eye three times a day for 14 days<br>* Other names: Vigamox®;|
| Active Comparator: Zymar®<br>gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride | Drug: gatifloxacin ophthalmic solution 0.3%<br>* 1 drop in study eye four times a day for 14 days<br>* Other names: ZYMAR®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | Percentage of subjects with strain resistance as determined by Minimum Inhibitory Concentration (MIC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2. | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14 | Mutant Prevention Concentration (MPC) of the conjunctiva (clear membrane covering the white surface of the eye) at day 14. MPC is the lowest drug concentration which prevents growth of any colony of bacteria on the conjunctiva. The MPC outcome measure was not analyzed due to the low number of data points. | Day 14 | 
| Minimum Inhibitory Concentration 50 (MIC50) at Day 14 | The Minimum Inhibitory Concentration 50 (MIC50) is the minimum concentration required to inhibit the growth of 50% of microorganisms. The MIC50 outcome measure was not analyzed due to the low number of data points. | Day 14 | 
| Minimum Inhibitory Concentration 90 (MIC90) at Day 14 | The Minimum Inhibitory Concentration 90 (MIC90) is the minimum concentration required to inhibit the growth of 90% of microorganisms. The MIC90 outcome measure was not analyzed due to the low number of data points. | Day 14 | 
| Minimum Inhibitory Concentration (MIC) Range at Day 14 | MIC range at day 14. MIC is the lowest concentration of an antimicrobial that inhibits the visible growth of a microorganism after incubation. The MIC cut-off values include: Intermediate is 1 to less than 2; Resistant is greater than or equal to 2. The MIC outcome measure was not analyzed due to the low number of data points. | Day 14 |