Anti-biotic Resistance
Conditions
Brief summary
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.
Interventions
DRUGmoxifloxacin 0.5% HCI ophthalmic solution
1 drop in study eye three times a day for 14 days
1 drop in study eye four times a day for 14 days
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mutant Prevention Concentration (MPC) of the Conjunctiva at Day 14 | 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. |
| Minimum Inhibitory Concentration 50 (MIC50) at Day 14 | 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. |
| Minimum Inhibitory Concentration 90 (MIC90) at Day 14 | 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. |
| Minimum Inhibitory Concentration (MIC) Range at Day 14 | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vigamox® Moxifloxacin 0.5% HCL ophthalmic solution | 32 |
| Zymar® Gatifloxacin 0.3% ophthalmic solution | 34 |
| Total | 66 |
Baseline characteristics
| Characteristic | Vigamox® | Zymar® | Total |
|---|---|---|---|
| Age Continuous | 60.3750 years STANDARD_DEVIATION 7.8278 | 62.5000 years STANDARD_DEVIATION 8.3892 | 61.625 years STANDARD_DEVIATION 8.1085 |
| Sex: Female, Male Female | 18 Participants | 21 Participants | 39 Participants |
| Sex: Female, Male Male | 14 Participants | 13 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 34 |
| serious Total, serious adverse events | 0 / 32 | 0 / 34 |
Outcome results
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.
Time frame: Day 14
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vigamox® | Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | 9.4 Percentage of Subjects |
| Zymar® | Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | 0 Percentage of Subjects |
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.
Time frame: Day 14
Population: 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.
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.
Time frame: Day 14
Population: 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.
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.
Time frame: Day 14
Population: 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.
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.
Time frame: Day 14
Population: 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.