Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery

This study has been completed.

First Received: June 30, 2006 Last Updated: June 21, 2007 History of Changes

Sponsor:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00348582

Purpose

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.

Condition	Intervention	Phase
Cataract	Drug: Ketorolac, Nepafenac	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	Acular LS vs. Nevanac in Post op Inflammation Following Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract Surgery

Drug Information available for: Ketorolac Ketorolac tromethamine Nepafenac

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

· 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

Exclusion Criteria:

· 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)..

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348582

Locations

United States, Pennsylvania
Dr. Francis
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:

Francis Mah, MD

University Pittsburgh Medical Center Eye and Ear Institute

More Information

No publications provided

Study ID Numbers:	5217
Study First Received:	June 30, 2006
Last Updated:	June 21, 2007
ClinicalTrials.gov Identifier:	NCT00348582 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Pathologic Processes
Eye Diseases
Cataract
Lens Diseases
Inflammation

ClinicalTrials.gov processed this record on February 08, 2010