Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%

This study has been completed.

First Received: January 7, 2008 Last Updated: March 17, 2009 History of Changes

Sponsor:	Bp Consulting, Inc
Information provided by:	Bp Consulting, Inc
ClinicalTrials.gov Identifier:	NCT00595543

Purpose

To compare bromfenac 0.09%, diclofenac sodium 0.1%, and ketorolac tromethamine 0.5% ophthalmic solutions for the treatment of acute pseudophakic CME after cataract surgery.

Condition	Intervention	Phase
Acute Pseudophakic Cystoid Macular Edema	Drug: Bromfenac Drug: Ketorolac Drug: Diclofenac	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Ketorolac Ketorolac tromethamine Bromfenac Tromethamine Bromfenac sodium

U.S. FDA Resources

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:

Acute Pseudophakic Cystoid Macular Edema [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Acuity [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	166
Study Start Date:	January 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Bromfenac 1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
2: Active Comparator	Drug: Ketorolac 1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
3: Active Comparator	Drug: Diclofenac 1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must be diagnosed with acute pseudophakic CME within 12 months of cataract surgery
Males and females 18 years and older
Able to provide written informed consent

Exclusion Criteria:

Complicated cataract surgery, particularly posterior capsule rupture and vitreous loss
Pre-Existing macular pathology, including macular edema, macular scar, macular hole, or macular pucker
History of Uveitis
Ipsilateral intraocular surgery prior to cataract surgery
CME greater than one year duration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595543

Locations

United States, Pennsylvania
Soll Eye Associates
Philadelphia, Pennsylvania, United States, 19124

Sponsors and Collaborators

Bp Consulting, Inc

Investigators

Principal Investigator:

David Rho, MD

Soll Eye Associates

More Information

No publications provided

Responsible Party:	Soll Eye Associates ( David Rho, MD )
Study ID Numbers:	5349
Study First Received:	January 7, 2008
Last Updated:	March 17, 2009
ClinicalTrials.gov Identifier:	NCT00595543 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Ketorolac
Physiological Effects of Drugs
Edema
Signs and Symptoms
Macular Edema
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Retinal Diseases
Eye Diseases

Cyclooxygenase Inhibitors
Diclofenac
Retinal Degeneration
Macular Degeneration
Enzyme Inhibitors
Pharmacologic Actions
Bromfenac
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Ketorolac Tromethamine
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010