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

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.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine

Drug

ketorolac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery

Other names: Acuvail

bromfenac

Drug

Drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery

Other names: Xibrom

Nepafenac

Drug

drug to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery

Other names: Nevanac

Primary outcomes

Aqueous PGE2 Inhibition

Time frame: Day 4 of treatment

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.

Sponsors and collaborators

Lead sponsor

Frank A. Bucci, Jr., M.D.

Other

Collaborators

Allergan

Registry information

Official study title

A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail, Xibrom and Nevanac in Patients Undergoing Phacoemulsification

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2010
First posted: Nov 30, 2009
Registry last updated: Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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