Trial Outcomes & Findings for TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension (NCT NCT00576251)
NCT ID: NCT00576251
Last Updated: 2010-03-02
Results Overview
Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
COMPLETED
PHASE3
221 participants
Day 4 - Test Of Cure (TOC) compared to Day 0
2010-03-02
Participant Flow
20 enrolling sites (private ophthalmology clinical offices) with first subject enrolled 10/29/07 and last subject enrolled 2/14/08)
Parallel, 1:1 ratio; double-masked
Participant milestones
| Measure |
Tobramycin 0.3%/Dexamethasone 0.05%
Tobramycin 0.3%/Dexamethasone 0.05%
|
TOBRADEX Ophthalmic Suspension
TOBRADEX Ophthalmic Suspension
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
112
|
|
Overall Study
COMPLETED
|
108
|
111
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Baseline characteristics by cohort
| Measure |
Tobramycin 0.3%/Dexamethasone 0.05%
n=109 Participants
Tobramycin 0.3%/Dexamethasone 0.05%
|
TOBRADEX Ophthalmic Suspension
n=112 Participants
TOBRADEX Ophthalmic Suspension
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 4 - Test Of Cure (TOC) compared to Day 0Microbiological success was declared if the pre-therapy pathogens were eradicated at the Exit Visit; conversely, microbiological failure was declared if pre-therapy pathogens persisted at the exit visit. The microbiological outcomes were calculated based on an algorithm that assessed whether pre-therapy pathogens were eradicated or persisted as demonstrated by comparative characterization of recovered bacteria.
Outcome measures
| Measure |
Tobramycin 0.3%/Dexamethasone 0.05%
n=109 Participants
Tobramycin 0.3%/Dexamethasone 0.05%
|
TOBRADEX Ophthalmic Suspension
n=112 Participants
TOBRADEX Ophthalmic Suspension
|
|---|---|---|
|
Percent of Patients Who Display Microbiological Success (Eradication of Baseline Pathogens at Day 4)
|
100.0 Percent of patients
|
94.4 Percent of patients
|
Adverse Events
Tobramycin 0.3%/Dexamethasone 0.05%
TOBRADEX Ophthalmic Suspension
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 Sponsor is allowed 30 days to review publication. With reasonable justification, sponsor may require the publication to be withheld an additional 60 days to obtain patent protection. Sponsor may request deletion of any trade secret, proprietary, or confidential information.
- Publication restrictions are in place
Restriction type: OTHER