Cataracts
Conditions
Brief summary
Approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either Acuvail, Xibrom, or Nevanac. Subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. Beginning one hour before surgery, 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. At the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15 cc of aqueous humor will be collected. The sample will be immediately stored on dry ice and shipped to a laboratory for analysis.
Interventions
One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery
DRUGbromfenac 0.09%
One day pre operative 1 drop BID then 3 doses pre op day of surgery
DRUGnepafenac 0.1%
One drop BID, 1 day pre operative and then 3 doses the day of surgery
Sponsors
Allergan
Frank A. Bucci, Jr., M.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
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 eye 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 ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery. * Contraindications to NSAIDS. * Active ocular infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Aqueous Penetration | day 4 of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acuvail Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery | 42 |
| Xibrom Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery | 42 |
| Nevanac One day before surgery 1 drop BID, then 3 doses pre op day of surgery | 42 |
| Total | 126 |
Baseline characteristics
| Characteristic | Xibrom | Nevanac | Acuvail | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 27 Participants | 21 Participants | 72 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 15 Participants | 21 Participants | 54 Participants |
| Age Continuous | 72 years STANDARD_DEVIATION 31 | 74 years STANDARD_DEVIATION 29 | 75 years STANDARD_DEVIATION 30 | 74 years STANDARD_DEVIATION 29 |
| Region of Enrollment United States | 42 participants | 42 participants | 42 participants | 126 participants |
| Sex: Female, Male Female | 26 Participants | 29 Participants | 26 Participants | 81 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 16 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 42 | 0 / 42 | 0 / 42 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 42 |
Outcome results
Primary
Peak Aqueous Penetration
Time frame: day 4 of treatment
Population: Protocol specified enrollment of 126 subjects and analysis was performed per protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acuvail | Peak Aqueous Penetration | 688.87 ng/ml | Standard Deviation 749.6 |
| Xibrom | Peak Aqueous Penetration | 67.64 ng/ml | Standard Deviation 62.4 |
| Nevanac | Peak Aqueous Penetration | 447.1 ng/ml | Standard Deviation 225.7 |