Cataract
Conditions
Keywords
Cataract extraction with intraocular lens implantation
Brief summary
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Interventions
sterile ophthalmic solution
DRUGplacebo
sterile ophthalmic solution
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for cataract surgery
Exclusion criteria
* Known hypersensitivity to bromfenac and salicylates
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Day 15 | Participants with SOIS of 0. 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 (None, Mild, Moderate, Severe) within one hour of instilling eye drop |
Countries
United States
Participant flow
Recruitment details
Study start date was 06/10/2008 and last participant to exit the study was 09/02/2008. This study was conducted in 18 study centers.
Pre-assignment details
A total of 126 subjects were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 63 were randomized to the bromfenac ophthalmic solution treatment group and 63 were randomized to the placebo treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Bromfenac Bromfenac Ophthalmic Solution 0.09%, Dosed 1 Drop Daily | 63 |
| Placebo Placebo, Dosed 1 Drop Daily | 63 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancelled surgery | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Bromfenac | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 67.1 years FULL_RANGE 10.8 | 68.6 years FULL_RANGE 8.6 | 67.9 years FULL_RANGE 9.8 |
| Sex: Female, Male Female | 40 Participants | 38 Participants | 78 Participants |
| Sex: Female, Male Male | 23 Participants | 25 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 46 / 61 | 61 / 61 |
| serious Total, serious adverse events | 2 / 61 | 0 / 61 |
Outcome results
Primary
Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero
Participants with SOIS of 0. 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
Population: Last Observation Carried Forward Analysis (LOCF). Intent to treat population (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | 28 Participants |
| Placebo | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | 20 Participants |
Secondary
Number of Participants That Are Pain Free
Participant description of being pain free taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop
Time frame: Day 1
Population: LOCF Analysis, ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac | Number of Participants That Are Pain Free | 51 Participants |
| Placebo | Number of Participants That Are Pain Free | 46 Participants |