Bromfenac BID Plus Prednisolone Acetate BID Versus Bromfenac BID Plus Prednisolone QID for the Prevention of Cystoid Macular Edema and Retinal Thickening

Retinal Thickening Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00469781
• Other study ID #: 5306
• Status: Completed
• Phase: Phase 4
• First received: May 4, 2007
• Last updated: September 23, 2008
• Start date: May 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Center For Excellence In Eye Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to determine if twice-daily dosing of prednisolone (Pred Forte) is as effective as four-times-daily dosing of prednisolone for the prevention of retinal thickening and cystoid macular edema (CME) when either regimen is used concomitantly with twice-daily bromfenac.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• · Male or female > 18 years of age scheduled to undergo cataract surgery

• Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams)

• Expected visual outcome of 20/25 or better.

• Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

• · Known contraindication to any study medication or any of their components

• Uncontrolled systemic disease

• Required use of ocular medications other than the study medications during the study

• Abnormal pre-operative OCTs

• Diabetic patients with a history of macular edema or diabetic retinopathy

• AMD, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease

• Only one eye of each patient can be enrolled

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cystoid Macular Edema,
• Macular Edema
• Retinal Thickening

Intervention

Drug:
• 2. Xibrom (Bromfenac)
Group 1 and 2: 1 drop(Instill one drop in the eye that was operated on twice daily)3 days prior to surgery and 4 doses during dilation immediately before the procedure. Use for 4 weeks after surgery.
• 1. Pred Forte
Group 1 Instill one drop in the eye that was operated on four times a day starting on day of surgery and use for four weeks. Group 2 Instill one drop in the eye that was operated on twice a day starting on day of surgery and use for four weeks.

Locations

Country	Name	City	State
United States	The Center for Excellence in Eye Care	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Center For Excellence In Eye Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cystoid Macular Edema		11 months	No
Secondary	Retinal Thickening		11 months	No