Post Operative Anterior Chamber Inflammation (Flare)
Conditions
Brief summary
Approximately 50 patients undergoing cataract surgery will be randomized in an even allocation (1:1) into two treatment groups, either ketorolac 0.45% BID or bromfenac 0.09% BID. Patients will be instructed to begin dosing study medication in the operative eye the day before surgery and continue dosing until day 14. KOWA flare measurements will be performed at postoperative day one and postoperative day 14. The amount of anterior chamber inflammation (flare) will be objectively measured.
Interventions
Acuvail to be given 1 drop BID for one day prior to surgery and then 1 drop BID post operatively for 14 days.
DRUGBromfenac 0.09%
Drug given one drop BID for one day pre operatively and then BID for 14 days post operatively
Sponsors
Allergan
Bucci Laser Vision Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects must be 18 years of age or older * Scheduled for cataract surgery by phacoemulsification * Subject must be willing to comply with all study requirements and be willing to give informed consent
Exclusion criteria
* Any subject that has a history of uveitis or active iritis * Subject can have no previous intraocular surgery with the exception of refractive surgery. but not within 6 months * No ocular use of prostaglandins within 2 weeks of surgery * Use of oral, injectable or topical steroids,nonsteroidal anti-inflammatory drugs (NSAIDs) or immunosuppressants within 14 days prior to surgery * Contraindications to NSAIDs * Active ocular infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anterior Chamber Inflammation (Flare) | Day 14 of treatment | Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xibrom Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days. | 25 |
| Acuvail Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Acuvail | Xibrom | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 19 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Age Continuous | 72 years STANDARD_DEVIATION 9 | 70 years STANDARD_DEVIATION 8 | 71 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 18 Participants | 16 Participants | 34 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Anterior Chamber Inflammation (Flare)
Anterior chamber flare measured by assessing the number of inflammatory cells in the anterior chamber.
Time frame: Day 14 of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Xibrom | Anterior Chamber Inflammation (Flare) | 24.48 photon count per msec (pc/ms) | Standard Deviation 21.94 |
| Acuvail | Anterior Chamber Inflammation (Flare) | 21.93 photon count per msec (pc/ms) | Standard Deviation 19.67 |