Trial Outcomes & Findings for Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery (NCT NCT01387464)
NCT ID: NCT01387464
Last Updated: 2021-11-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Approximately 3 hours post last dose
Results posted on
2021-11-19
Participant Flow
Participant milestones
| Measure |
ISV-303
0.075% bromfenac in DuraSite vehicle dosed QD
|
Bromday
0.09% bromfenac dosed QD
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
Safety Population
|
30
|
29
|
|
Overall Study
Per-Protocol Population
|
29
|
29
|
|
Overall Study
COMPLETED
|
29
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aqueous Humor Concentration of InSite Vision (ISV) 303 (Bromfenac in DuraSite) to Bromday Once Daily (QD) Prior to Cataract Surgery
Baseline characteristics by cohort
| Measure |
ISV-303
n=30 Participants
0.075% bromfenac in DuraSite vehicle dosed QD
|
Bromday
n=30 Participants
0.09% bromfenac dosed QD
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
68.2 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
69.4 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Age, Customized
18-30 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
31-50 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
51-70 years
|
10 participants
n=5 Participants
|
18 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Age, Customized
>70 years
|
19 participants
n=5 Participants
|
12 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 3 hours post last dosePopulation: Per-Protocol Population
Outcome measures
| Measure |
ISV-303
n=29 Participants
0.075% bromfenac in DuraSite vehicle dosed QD
|
Bromday
n=29 Participants
0.09% bromfenac dosed QD
|
|---|---|---|
|
Mean Aqueous Humor Bromfenac Concentration
|
49.3 ng/mL
Standard Deviation 41.87
|
23.7 ng/mL
Standard Deviation 16.31
|
Adverse Events
ISV-303
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bromday
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
Restriction type: OTHER