Trial Outcomes & Findings for Topical Antibiotics and Intravitreous Injections (NCT NCT00410891)
NCT ID: NCT00410891
Last Updated: 2017-11-06
Results Overview
The percentage of patients with a positive bacterial culture following administration of study treatment is presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
129 participants
Primary outcome timeframe
Study day 1, assessed following administration of study treatment
Results posted on
2017-11-06
Participant Flow
Participant milestones
| Measure |
Topical Antibiotic
topical gatifloxacin 4 times per day
gatifloxacin
|
|---|---|
|
Overall Study
STARTED
|
129
|
|
Overall Study
COMPLETED
|
129
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Antibiotics and Intravitreous Injections
Baseline characteristics by cohort
| Measure |
Topical Antibiotic
n=129 Participants
topical gatifloxacin 4 times per day
gatifloxacin
|
|---|---|
|
Age, Continuous
|
77 years
STANDARD_DEVIATION 13 • n=93 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
|
Conjunctival Bacterial Flora
Coagulase-negative staphylococcus
|
75 percentage of patients
n=93 Participants
|
|
Conjunctival Bacterial Flora
Staphylococcus aureus
|
7 percentage of patients
n=93 Participants
|
|
Conjunctival Bacterial Flora
Gram-negative rods
|
6 percentage of patients
n=93 Participants
|
|
Conjunctival Bacterial Flora
Streptococcus species
|
7 percentage of patients
n=93 Participants
|
PRIMARY outcome
Timeframe: Study day 1, assessed following administration of study treatmentThe percentage of patients with a positive bacterial culture following administration of study treatment is presented.
Outcome measures
| Measure |
Topical Antibiotic
n=129 Participants
topical gatifloxacin 4 times per day
gatifloxacin
|
|---|---|
|
Positive Culture
|
8 percentage of patients
|
Adverse Events
Topical Antibiotic
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