Cataract, Inflammation, Pain
Conditions
Keywords
cataract surgery
Brief summary
This is an efficacy study 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
* 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 |
|---|---|---|
| Ocular Inflammation | Day 15 | The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Pain | Day 1 | The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of None on the pain scale of the Ocular Comfort Grading Assessment in the subject diary. |
Countries
United States
Participant flow
Recruitment details
This study was a multi-center, randomized, double-masked, parallel-group, placebo-controlled study, the first subject was enrolled 05/05/2011 and the last subject exited the study 07/29/2011.
Pre-assignment details
440 subjects were enrolled from 39 clinical sites in the United States, of which 416 subjects received at least 1 dose of bromfenac or placebo.
Participants by arm
| Arm | Count |
|---|---|
| Bromfenac Ophthalmic Solution Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Bromfenac Ophthalmic Solution: Sterile ophthalmic solution | 222 |
| Placebo One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution | 218 |
| Total | 440 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 3 | 10 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Total | Placebo | Bromfenac Ophthalmic Solution |
|---|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 10.19 | 68.5 years STANDARD_DEVIATION 9.68 | 68.4 years STANDARD_DEVIATION 10.7 |
| Iris Color (Study Eye) Blue | 122 participants | 65 participants | 57 participants |
| Iris Color (Study Eye) Brown | 202 participants | 93 participants | 109 participants |
| Iris Color (Study Eye) Gray | 6 participants | 5 participants | 1 participants |
| Iris Color (Study Eye) Green | 45 participants | 21 participants | 24 participants |
| Iris Color (Study Eye) Hazel | 64 participants | 33 participants | 31 participants |
| Iris Color (Study Eye) Other | 1 participants | 1 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 17 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 59 Participants | 31 Participants | 28 Participants |
| Race (NIH/OMB) White | 329 Participants | 162 Participants | 167 Participants |
| Region of Enrollment United States | 440 participants | 218 participants | 222 participants |
| Sex: Female, Male Female | 287 Participants | 146 Participants | 141 Participants |
| Sex: Female, Male Male | 153 Participants | 72 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 29 / 212 | 54 / 204 |
| serious Total, serious adverse events | 3 / 212 | 4 / 204 |
Outcome results
Primary
Ocular Inflammation
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
Time frame: Day 15
Population: LOCF Analysis, ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac Ophthalmic Solution | Ocular Inflammation | 108 eyes |
| Placebo | Ocular Inflammation | 53 eyes |
Secondary
Ocular Pain
The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of None on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.
Time frame: Day 1
Population: LOCF Analysis, ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bromfenac Ophthalmic Solution | Ocular Pain | 175 eyes |
| Placebo | Ocular Pain | 108 eyes |