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

NCT ID: NCT01021761

Last Updated: 2011-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

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.

Detailed Description

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Conditions

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Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Xibrom

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

Group Type ACTIVE_COMPARATOR

Bromfenac

Intervention Type DRUG

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

Nevanac

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

Group Type ACTIVE_COMPARATOR

nepafenac

Intervention Type DRUG

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

Acuvail

Acuvail to be given preoperatively. One drop 2 times (BID), 1 day pre op and day of surgery 3 doses prior to surgery.

Group Type ACTIVE_COMPARATOR

Ketorolac Tromethamine

Intervention Type DRUG

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

Interventions

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Ketorolac Tromethamine

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

Intervention Type DRUG

Bromfenac

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

Intervention Type DRUG

nepafenac

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

Intervention Type DRUG

Other Intervention Names

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Acuvail Xibrom Nevanac

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Frank A Bucci, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Bucci Laser Vision

Countries

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United States

Other Identifiers

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2009 0199

Identifier Type: -

Identifier Source: org_study_id