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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.
Sponsor:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00595543
First received: January 7, 2008
Last updated: March 17, 2009
Last verified: March 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Edema
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
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

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

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

ClinicalTrials.gov processed this record on May 23, 2013