Inflammation, Pain
Conditions
Keywords
Pain and Inflammation as a function of cataract surgery
Brief summary
Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery
Interventions
sterile ophthalmic solution
DRUGPlacebo Comparator
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
* Male or female at least 18 years of age who are scheduled for unilateral cataract surgery
Exclusion criteria
* Have known hypersensitivity to bromfenac or to any component of the investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summed Ocular Inflammation Score (SOIS) of Zero | Day 15 (Primary Endpoint) | Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 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 |
|---|---|---|
| Pain Free | Day 1 | Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe. |
Countries
United States
Participant flow
Recruitment details
The first participant entered the study on 02/09/2009, and last participant exited the study on 07/06/2009. This study took place at 41 sites in the USA
Pre-assignment details
152 participants were randomized to the bromfenac ophthalmic solution 0.09% treatment group and 147 were randomized to the placebo treatment group. One hundred forty six of 152 participants (96.1%) in the bromfenac ophthalmic solution 0.09% treatment group and 144/147 (98.0%) participants in the placebo treatment group completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Bromfenac Ophthalmic Solution 0.09% one drop daily in study eye for 2 weeks | 152 |
| Placebo one drop daily in study eye for 2 weeks | 147 |
| Total | 299 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancelled surgery | 4 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Bromfenac Ophthalmic Solution 0.09% | Placebo | Total |
|---|---|---|---|
| Age Continuous | 70.4 years | 69.1 years | 69.8 years |
| Sex: Female, Male Female | 89 Participants | 99 Participants | 188 Participants |
| Sex: Female, Male Male | 63 Participants | 48 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 69 / 147 | 86 / 144 |
| serious Total, serious adverse events | 0 / 147 | 3 / 144 |
Outcome results
Primary
Summed Ocular Inflammation Score (SOIS) of Zero
Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)
Time frame: Day 15 (Primary Endpoint)
Population: Last observation carried forward (LOCF) Analysis; Intent to treat (ITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac Ophthalmic Solution 0.09% | Summed Ocular Inflammation Score (SOIS) of Zero | 70 participants |
| Placebo | Summed Ocular Inflammation Score (SOIS) of Zero | 36 participants |
Secondary
Pain Free
Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.
Time frame: Day 1
Population: Last observation carried forward (LOCF) Analysis, Intent to treat (ITT) Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac Ophthalmic Solution 0.09% | Pain Free | 135 participants |
| Placebo | Pain Free | 105 participants |