A Phase 4 interventional study of moxifloxacin 0.5% HCI ophthalmic solution and gatifloxacin ophthalmic solution 0.3% in Anti-biotic Resistance, sponsored by Allergan. Completed at 2 sites in 2 countries. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-19.
Sponsored by Allergan (part of AbbVie) · Phase 4, Interventional, and Basic science
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.
Allergan is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 93 completed or terminated interventional studies of FDA-regulated products, 91 (98%) have results posted.
First submitted before Allergan became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
moxifloxacin 0.5% (m mg/mL), boric acid, sodium chloride, and purified water
Drug: moxifloxacin 0.5% HCI ophthalmic solution
gatifloxacin 0.3% (3 mg/mL), benzalkonium chloride 0.005%, edetate disodium; purified water and sodium chloride
Drug: gatifloxacin ophthalmic solution 0.3%
1 drop in study eye three times a day for 14 days
Also known as: Vigamox®
1 drop in study eye four times a day for 14 days
Also known as: ZYMAR®
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
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
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
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
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
| Milestone | Vigamox® | Zymar® |
|---|---|---|
| Started | 32 | 34 |
| Completed | 32 | 34 |
| Not completed | 0 | 0 |
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.
| Percentage of Subjects | Vigamox® | Zymar® |
|---|---|---|
| Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14 | 9.4 | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vigamox® | — | 0/32 (0%) | 0/32 (0%) |
| Zymar® | — | 0/34 (0%) | 0/34 (0%) |
| Age Continuous(years) | Vigamox® | Zymar® | Total |
|---|---|---|---|
| Mean | 60.3750 ± 7.8278 | 62.5000 ± 8.3892 | 61.625 ± 8.1085 |
| Sex: Female, Male(Participants) | Vigamox® | Zymar® | Total |
|---|---|---|---|
| Female | 18 | 21 | 39 |
| Male | 14 | 13 | 27 |
The record gives a start of Mar 2009, a primary completion of Sep 2009 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2011, 2 years 3 months after primary completion.
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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Moxifloxacin · Gatifloxacin