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

Acute Pseudophakic Cystoid Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595543
• Other study ID #: 5349
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2008
• Last updated: March 17, 2009
• Start date: January 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pseudophakic Cystoid Macular Edema
• Macular Edema

Intervention

Drug:
• Bromfenac
1 drop (in the eye) Instill one drop in the affected eye twice daily for three months
• Ketorolac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months
• Diclofenac
1 drop (in the eye) Instill one drop in the affected eye four times daily for three months

Locations

Country	Name	City	State
United States	Soll Eye Associates	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bp Consulting, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Pseudophakic Cystoid Macular Edema		5 months	No
Secondary	Visual Acuity		5 months	No