MedDataX Logo

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

NCT ID: NCT01001806

Last Updated: 2011-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataracts

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acuvail

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

Group Type ACTIVE_COMPARATOR

Ketorolac Tromethamine 0.45%

Intervention Type DRUG

One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery

Xibrom

Xibrom to be given 1 drop 2 times daily (BID) the day before surgery and 3 doses the day of surgery prior to surgery

Group Type ACTIVE_COMPARATOR

bromfenac 0.09%

Intervention Type DRUG

One day pre operative 1 drop BID then 3 doses pre op day of surgery

Nevanac

One day before surgery 1 drop 2 times daily (BID), then 3 doses the day of surgery

Group Type ACTIVE_COMPARATOR

nepafenac 0.1%

Intervention Type DRUG

One drop BID, 1 day pre operative and then 3 doses the day of surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketorolac Tromethamine 0.45%

One drop BID the day before surgery and then 3 doses the day of surgery prior to surgery

Intervention Type DRUG

bromfenac 0.09%

One day pre operative 1 drop BID then 3 doses pre op day of surgery

Intervention Type DRUG

nepafenac 0.1%

One drop BID, 1 day pre operative and then 3 doses the day of surgery

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Acuvail Xibrom Nevanac

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Allergan

INDUSTRY

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frank A Bucci, Jr.,, MD

Role: PRINCIPAL_INVESTIGATOR

Bucci Laser Vision Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-0199

Identifier Type: -

Identifier Source: org_study_id