Cataract Surgery
Conditions
Brief summary
This is a safety and efficacy study of bromfenac ophthalmic solution
Interventions
sterile opthalmic solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female greater than or equal to 18 years of age, and scheduled for cataract surgery
Exclusion criteria
* Active corneal pathology in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Day 15 | Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Are Pain Free | Day 1 | Participant description of being pain free taken from patient questionnaire with multiple possible responses |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bromfenac Ophthalmic Solution 0.18% | 277 |
| Xibrom 0.09% | 291 |
| Total | 568 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Enrollment met/over-enrolled | 10 | 9 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 3 |
Baseline characteristics
| Characteristic | Bromfenac Ophthalmic Solution 0.18% | Xibrom 0.09% | Total |
|---|---|---|---|
| Age Continuous | 68.8 years | 68.6 years | 68.7 years |
| Sex: Female, Male Female | 169 Participants | 154 Participants | 323 Participants |
| Sex: Female, Male Male | 108 Participants | 137 Participants | 245 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 266 | 19 / 278 |
| serious Total, serious adverse events | 2 / 266 | 3 / 278 |
Outcome results
Primary
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Participants with SOIS of 1. Scale: 0=0 cells (complete absence); 0.5=1-5 cells (trace); 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)
Time frame: Day 15
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac Ophthalmic Solution 0.18% | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | 157 Participant |
| Xibrom 0.09% | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | 164 Participant |
Secondary
Number of Participants That Are Pain Free
Participant description of being pain free taken from patient questionnaire with multiple possible responses
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac Ophthalmic Solution 0.18% | Number of Participants That Are Pain Free | 221 Participant |
| Xibrom 0.09% | Number of Participants That Are Pain Free | 235 Participant |