Text Size

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

January 7, 2008
March 17, 2009
January 2008
March 2009   (final data collection date for primary outcome measure)
Acute Pseudophakic Cystoid Macular Edema [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00595543 on ClinicalTrials.gov Archive Site
Visual Acuity [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Acute Pseudophakic Cystoid Macular Edema: Bromfenac 0.09% Versus Diclofenac Sodium 0.1% Versus Ketorolac Tromethamine 0.5%
Not Provided

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Pseudophakic Cystoid Macular Edema
  • Drug: Bromfenac
    1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
  • Drug: Ketorolac
    1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
  • Drug: Diclofenac
    1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
  • Active Comparator: 1
    Intervention: Drug: Bromfenac
  • Active Comparator: 2
    Intervention: Drug: Ketorolac
  • Active Comparator: 3
    Intervention: Drug: Diclofenac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
166
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00595543
5349
Not Provided
David Rho, MD, Soll Eye Associates
Bp Consulting, Inc
Not Provided
Principal Investigator: David Rho, MD Soll Eye Associates
Bp Consulting, Inc
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP