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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vigamox® | Active Comparator | moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water |
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| Zymar® | Active Comparator | gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxifloxacin 0.5% HCI ophthalmic solution | Drug | 1 drop in study eye three times a day for 14 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis | Minnesota | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Vigamox® | Moxifloxacin 0.5% HCL ophthalmic solution |
| FG001 | Zymar® | Gatifloxacin 0.3% ophthalmic solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| gatifloxacin ophthalmic solution 0.3% | Drug | 1 drop in study eye four times a day for 14 days |
|
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| 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 |
| Saskatoon |
| Saskatchewan |
| Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vigamox® | Moxifloxacin 0.5% HCL ophthalmic solution |
| BG001 | Zymar® | Gatifloxacin 0.3% ophthalmic solution |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. One patient in the Zymar® group did not have cultures performed at Day 14. | Posted | Number | Percentage of Subjects | Day 14 |
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| Secondary | 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. | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points. | Posted | Number | micrograms per milliliter (ug/mL) | Day 14 |
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| Secondary | 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. | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points. | Posted | Number | micrograms per milliliter (ug/mL) | Day 14 |
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| Secondary | 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. | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points. | Posted | Number | micrograms per milliliter (ug/mL) | Day 14 |
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| Secondary | 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. | The microbiological (mITT) population consisted of randomized subjects who received study product and had at least one post-baseline microbiological efficacy measure. Data for this outcome measure were not analyzed due to the low number of data points. | Posted | Number | micrograms per milliliter (ug/mL) | Day 14 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vigamox® | Moxifloxacin 0.5% HCL ophthalmic solution | 0 | 32 | 0 | 32 | ||
| EG001 | Zymar® | Gatifloxacin 0.3% ophthalmic solution | 0 | 34 | 0 | 34 |
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Only a small number of resistant species were obtained at the study endpoints. Therefore, some outcome measures were not able to be analyzed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D000077734 | Gatifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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