Trial Outcomes & Findings for Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers (NCT NCT01190878)
NCT ID: NCT01190878
Last Updated: 2021-11-19
Results Overview
Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
169 participants
Primary outcome timeframe
15 days
Results posted on
2021-11-19
Participant Flow
Participant milestones
| Measure |
ISV-303 BID
ISV-303: 0.075% bromfenac in DuraSite dosed BID
|
ISV-303 QD
ISV-303: 0.075% bromfenac in DuraSite dosed QD
|
Xibrom BID
Xibrom™: 0.09% bromfenac dosed BID
|
DuraSite Vehicle BID
DuraSite Vehicle: Vehicle dosed BID
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
45
|
42
|
42
|
|
Overall Study
COMPLETED
|
37
|
42
|
37
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
5
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers
Baseline characteristics by cohort
| Measure |
ISV-303 BID
n=40 Participants
ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
|
ISV-303 QD
n=45 Participants
ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
|
Xibrom BID
n=42 Participants
Xibrom™: Xibrom dosed BID
|
DuraSite Vehicle BID
n=42 Participants
DuraSite Vehicle: Vehicle Dosed BID
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 7.70 • n=5 Participants
|
70.9 years
STANDARD_DEVIATION 9.75 • n=7 Participants
|
68.6 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 9.30 • n=4 Participants
|
69.5 years
STANDARD_DEVIATION 9.47 • n=21 Participants
|
|
Age, Customized
18-30 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
Age, Customized
31-50 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Age, Customized
51-70 years
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
25 participants
n=4 Participants
|
91 participants
n=21 Participants
|
|
Age, Customized
>70 years
|
18 participants
n=5 Participants
|
23 participants
n=7 Participants
|
19 participants
n=5 Participants
|
15 participants
n=4 Participants
|
75 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
89 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method.
Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is \> 50 cells.
Outcome measures
| Measure |
ISV-303 BID
n=40 Participants
ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
|
ISV-303 QD
n=45 Participants
ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
|
Xibrom BID
n=42 Participants
Xibrom™: Xibrom dosed BID
|
DuraSite Vehicle BID
n=42 Participants
DuraSite Vehicle: Vehicle Dosed BID
|
|---|---|---|---|---|
|
Ocular Inflammation
|
21 participants
|
24 participants
|
18 participants
|
8 participants
|
Adverse Events
ISV-303 BID
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
ISV-303 QD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Xibrom BID
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
DuraSite Vehicle BID
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ISV-303 BID
n=40 participants at risk
ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
|
ISV-303 QD
n=45 participants at risk
ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
|
Xibrom BID
n=42 participants at risk
Xibrom™: Xibrom dosed BID
|
DuraSite Vehicle BID
n=42 participants at risk
DuraSite Vehicle: Vehicle Dosed BID
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Faecaloma
|
2.5%
1/40 • 29 days
|
0.00%
0/45 • 29 days
|
0.00%
0/42 • 29 days
|
0.00%
0/42 • 29 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/40 • 29 days
|
0.00%
0/45 • 29 days
|
2.4%
1/42 • 29 days
|
0.00%
0/42 • 29 days
|
Other adverse events
| Measure |
ISV-303 BID
n=40 participants at risk
ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
|
ISV-303 QD
n=45 participants at risk
ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
|
Xibrom BID
n=42 participants at risk
Xibrom™: Xibrom dosed BID
|
DuraSite Vehicle BID
n=42 participants at risk
DuraSite Vehicle: Vehicle Dosed BID
|
|---|---|---|---|---|
|
Eye disorders
Iritis
|
0.00%
0/40 • 29 days
|
8.9%
4/45 • 29 days
|
2.4%
1/42 • 29 days
|
2.4%
1/42 • 29 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER