A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)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 0.15cc 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 Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification

Conditions
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Cataracts

Intervention / Treatment
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* Drug: Ketorolac Tromethamine
* Drug: Bromfenac
* Drug: nepafenac


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 Subjects 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 o previous eye surgery with the exception of refractive surgery but not within 6 month No ocular use of prostaglandins within 2 weeks of surgery Use of oral, injectable or topical ophthalmic steroids, NSAIDs of immunosuppressants within 14 days prior to surgery Contraindications to nonsteroidal anti-inflammatory drugs (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: Xibrom<br>Xibrom to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery | Drug: Bromfenac<br>* Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery<br>* Other names: Xibrom;|
| Active Comparator: Nevanac<br>Nevanac to be given 1 drop 2 times (BID) the day before surgery and 3 doses pre op the day of surgery prior to surgery | Drug: nepafenac<br>* drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery<br>* Other names: Nevanac;|
| Active Comparator: Acuvail<br>Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery. | Drug: Ketorolac Tromethamine<br>* ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery<br>* Other names: Acuvail;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous PGE2 Inhibition | A spectroscopic quantification of PGE2 was performed on the aqueous humor samples collected with the results measured in pg/ml. PGE2 levels below 50 pg/ml were considered below the level of detection. | Day 4 of treatment |