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

NCT00469781 | Completed Phase 4

• 1 other identifier: 5306
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystoid Macular Edema,; Retinal Thickening

Outcome Measures

Primary Outcomes (1)

• Cystoid Macular Edema

  11 months

Secondary Outcomes (1)

• Retinal Thickening

  11 months

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: 1. Pred Forte

2

OTHER

Drug: 2. Xibrom (Bromfenac)

Interventions

2. Xibrom (Bromfenac) DRUG

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.

2

1. Pred Forte DRUG

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · 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

You may not qualify if:

• · 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

Sponsors & Collaborators

• Center For Excellence In Eye Care: lead

Study Sites (1)

The Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

bromfenac

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Carlos Buznego, MD

  The Center for Excellence in Eye Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2007
• First Posted: May 7, 2007
• Study Start: May 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

US (1)