Trial Outcomes & Findings for A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID) (NCT NCT01023724)
NCT ID: NCT01023724
Last Updated: 2011-08-26
Results Overview
Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Day 14 of treatment
Results posted on
2011-08-26
Participant Flow
Participant milestones
| Measure |
Xibrom
Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
|
Acuvail
Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
Baseline characteristics by cohort
| Measure |
Xibrom
n=25 Participants
Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
|
Acuvail
n=25 Participants
Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age Continuous
|
70 years
STANDARD_DEVIATION 8 • n=99 Participants
|
72 years
STANDARD_DEVIATION 9 • n=107 Participants
|
71 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
25 participants
n=107 Participants
|
50 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 14 of treatmentAnterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.
Outcome measures
| Measure |
Xibrom
n=25 Participants
Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
|
Acuvail
n=25 Participants
Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
|
|---|---|---|
|
Anterior Chamber Inflammation (Flare)
|
24.48 photon count per msec (pc/ms)
Standard Deviation 21.94
|
21.93 photon count per msec (pc/ms)
Standard Deviation 19.67
|
Adverse Events
Xibrom
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acuvail
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