Trial Outcomes & Findings for One Hour Preoperative Gatifloxacin (NCT NCT00350363)
NCT ID: NCT00350363
Last Updated: 2015-01-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
2 weeks
Results posted on
2015-01-29
Participant Flow
Participant milestones
| Measure |
1 Day of Gatifloxacin
eyes receiving gatifloxacin 4 times per day 1 day before surgery
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One Hour Preoperative Gatifloxacin
Baseline characteristics by cohort
| Measure |
1 Day of Gatifloxacin
n=60 Participants
eyes receiving gatifloxacin 4 times per day 1 day before surgery
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksOutcome measures
| Measure |
1 Day of Gatifloxacin
n=60 Participants
eyes receiving gatifloxacin 4 times per day 1 day before surgery
|
|---|---|
|
Number of Participant With Positive Culture
|
17 participants
|
Adverse Events
1 Day of Gatifloxacin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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
- Publication restrictions are in place