NCT00348582

Brief Summary

The purpose of this study is to compare the clinical outcomes, safety and efficacy in patients randomized to receive either ketorolac or nepafanac following cataract surgery.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

June 25, 2007

Status Verified

June 1, 2007

First QC Date

June 30, 2006

Last Update Submit

June 21, 2007

Conditions

Cataract

Interventions

Ketorolac, NepafenacDRUG

Eligibility Criteria

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

You may qualify if:

  • · Male or female \> 18 years of age scheduled to undergo cataract surgery
  • Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)
  • Ability to provide informed consent and likely to complete all study visits

You may not qualify if:

  • · Known contraindication to any study medication or any of their components
  • Uncontrolled systemic disease
  • Required use of ocular medications other than the study medications during the study
  • Abnormal pre-operative OCTs if obtainable
  • Diabetic patients
  • Use of oral NSAIDS
  • Patients with ocular disease (macula degeneration, glaucoma, corneal disease) which reduces the potential visual rehabilitation (patients will ocular disease that will no preclude achievement of a 20/20 visual outcome may be included)..

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Francis

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Ketorolacnepafenac

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Francis Mah, MD

    University Pittsburgh Medical Center Eye and Ear Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Last Updated

June 25, 2007

Record last verified: 2007-06

Locations

US(1)