NCT01021761

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 26, 2011

Completed
Last Updated

August 31, 2011

Status Verified

August 1, 2011

Enrollment Period

2 months

First QC Date

November 25, 2009

Results QC Date

May 25, 2011

Last Update Submit

August 26, 2011

Conditions

Cataracts

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Xibrom

ACTIVE COMPARATOR

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

Nevanac

ACTIVE COMPARATOR

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

Acuvail

ACTIVE COMPARATOR

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

Interventions

Ketorolac TromethamineDRUG

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

Also known as: Acuvail
Acuvail
BromfenacDRUG

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

Also known as: Xibrom
Xibrom
nepafenacDRUG

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

Also known as: Nevanac
Nevanac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cataract

Interventions

Ketorolac TromethamineKetorolacbromfenacnepafenac

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Frank A. Bucci, Jr., MD
Organization
Bucci Laser Vision
Buccivision@aol.com
570-825-5949

Study Officials

  • Frank A Bucci, Jr., MD

    Bucci Laser Vision

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 30, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

August 31, 2011

Results First Posted

August 26, 2011

Record last verified: 2011-08