Cataract
Conditions
Keywords
Cataract extraction, intraocular lens implantation
Brief summary
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Interventions
DRUGBromfenac
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; 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 (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 19 sites, first participant entered the study 06/03/2008 and last participant completed the study 08/29/2008.
Pre-assignment details
A total of 156 participants were randomized to investigational product and were included in the Intent-to-Treat (ITT) population; 78 were randomized to the bromfenac ophthalmic solution treatment group and 78 were randomized to the placebo treatment group.
Participants by arm
| Arm | Count |
|---|---|
| Bromfenac Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily | 78 |
| Placebo Placebo, dosed 1 drop daily | 78 |
| Total | 156 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Over-enrolled/surgery postponed | 3 | 6 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Bromfenac | Placebo | Total |
|---|---|---|---|
| Age Continuous | 68.7 years | 68.0 years | 68.4 years |
| Sex: Female, Male Female | 45 Participants | 48 Participants | 93 Participants |
| Sex: Female, Male Male | 33 Participants | 30 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 73 | 19 / 73 |
| serious Total, serious adverse events | 0 / 73 | 0 / 73 |
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; 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), ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | 36 participants |
| Placebo | Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | 23 participants |
Secondary
Number of Participants That Are Pain Free
Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses
Time frame: Day 1
Population: LOCF Analysis, ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac | Number of Participants That Are Pain Free | 65 participants |
| Placebo | Number of Participants That Are Pain Free | 40 participants |