A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification

Study Overview
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Brief Summary
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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.

Official Title
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A Comparison of Peak Aqueous Penetration of Acuvail, Xibrom, and Nevanac in Patients Undergoing Phacoemulsification

Conditions
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Cataracts

Intervention / Treatment
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* Drug: Ketorolac Tromethamine 0.45%
* Drug: bromfenac 0.09%
* Drug: nepafenac 0.1%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acuvail<br>Acuvail to be given preoperatively. One drop 2 times daily (BID), 1 day pre op and day of surgery 3 doses prior to surgery | Drug: Ketorolac Tromethamine 0.45%<br>* One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery<br>* Other names: Acuvail;|
| Active Comparator: Xibrom<br>Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery | Drug: bromfenac 0.09%<br>* One day pre operative 1 drop BID then 3 doses pre op day of surgery<br>* Other names: Xibrom;|
| Active Comparator: Nevanac<br>One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery | Drug: nepafenac 0.1%<br>* One drop BID, 1 day pre operative and then 3 doses the day of surgery<br>* Other names: Nevanac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Aqueous Penetration |  | day 4 of treatment |