Trial Outcomes & Findings for A Comparison of Three Different Formulations of Prednisolone Acetate 1% (NCT NCT00345046)
NCT ID: NCT00345046
Last Updated: 2015-06-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
2 months
Results posted on
2015-06-03
Participant Flow
Recruitment period Feb 2005 - Jun 2008 Subjects were recruited from surgical schedule.
One subject was disqualified due to previous laser treatment. One subject did not receive study medication therefore was discontinued from study participation.
Participant milestones
| Measure |
Pred Forte 1%
Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
|
EconPred Plus 1%
EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
|
Prednisolone Acetate 1%
Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
22
|
16
|
|
Overall Study
COMPLETED
|
17
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Pred Forte 1%
Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
|
EconPred Plus 1%
EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
|
Prednisolone Acetate 1%
Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
1
|
2
|
Baseline Characteristics
A Comparison of Three Different Formulations of Prednisolone Acetate 1%
Baseline characteristics by cohort
| Measure |
Pred Forte
n=18 Participants
Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
Pred Forte: Four drops daily decreasing to once daily over four weeks.
|
EconoPred Plus
n=21 Participants
EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks.
|
Prednisolone Acetate
n=12 Participants
Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 15.2 • n=99 Participants
|
68.3 years
STANDARD_DEVIATION 13.0 • n=107 Participants
|
65.7 years
STANDARD_DEVIATION 16.6 • n=206 Participants
|
66.5 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 2 monthsOutcome measures
| Measure |
Pred Forte 1%
n=18 Participants
Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
|
Econo Pred Plus 1%
n=21 Participants
EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks.
|
Predisolone Acetate 1%
n=12 Participants
Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks.
|
|---|---|---|---|
|
Percent Change in Flare at Resolution
|
64.8 Percent change in flare
Standard Deviation 15.2
|
68.3 Percent change in flare
Standard Deviation 13.0
|
65.7 Percent change in flare
Standard Deviation 16.6
|
Adverse Events
Pred Forte 1%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EconoPred Plus 1%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prednisolone Acetate 1%
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