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

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ClinicalTrials.gov Identifier: NCT00595543
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : March 19, 2009
Sponsor:
Information provided by:
Bp Consulting, Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Pseudophakic Cystoid Macular Edema Drug: Bromfenac Drug: Ketorolac Drug: Diclofenac Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: Bromfenac
1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
Active Comparator: 2 Drug: Ketorolac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
Active Comparator: 3 Drug: Diclofenac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months



Primary Outcome Measures :
  1. Acute Pseudophakic Cystoid Macular Edema [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 5 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: David Rho, MD, Soll Eye Associates
ClinicalTrials.gov Identifier: NCT00595543     History of Changes
Other Study ID Numbers: 5349
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diclofenac
Ketorolac
Ketorolac Tromethamine
Bromfenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action