Trial Outcomes & Findings for A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms (NCT NCT00874887)
NCT ID: NCT00874887
Last Updated: 2011-12-19
Results Overview
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.
COMPLETED
PHASE4
66 participants
Day 14
2011-12-19
Participant Flow
Participant milestones
| Measure |
Vigamox®
Moxifloxacin 0.5% HCL ophthalmic solution
|
Zymar®
Gatifloxacin 0.3% ophthalmic solution
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate if Benzalkonium Chloride (BAK) in a Quinolone Eyedrop Reduces the Likelihood of Developing Resistant Organisms
Baseline characteristics by cohort
| Measure |
Vigamox®
n=32 Participants
Moxifloxacin 0.5% HCL ophthalmic solution
|
Zymar®
n=34 Participants
Gatifloxacin 0.3% ophthalmic solution
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
60.3750 years
STANDARD_DEVIATION 7.8278 • n=5 Participants
|
62.5000 years
STANDARD_DEVIATION 8.3892 • n=7 Participants
|
61.625 years
STANDARD_DEVIATION 8.1085 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
| Measure |
Vigamox®
n=32 Participants
Moxifloxacin 0.5% HCL ophthalmic solution
|
Zymar®
n=33 Participants
Gatifloxacin 0.3% ophthalmic solution
|
|---|---|---|
|
Percentage of Subjects With Strain Resistance of the Conjunctiva as Determined by Minimum Inhibitory Concentration (MIC) at Day 14
|
9.4 Percentage of Subjects
|
0 Percentage of Subjects
|
SECONDARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 14Population: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Vigamox®
Zymar®
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER