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

Sponsor

Center For Excellence In Eye Care (Other)

Overall Status

Completed

CT.gov ID

NCT00469781

Collaborator

(none)

Enrollment

Location

Arms

16.1

Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystoid Macular Edema, Retinal Thickening	Drug: 2. Xibrom (Bromfenac) Drug: 1. Pred Forte	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

95 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Sep 1, 2008

Actual Study Completion Date :

Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: 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.
Other: 2	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.

Arm

Intervention/Treatment

Active Comparator: 1

Drug: 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.

Other: 2

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.

Outcome Measures

Primary Outcome Measures

Cystoid Macular Edema [11 months]

Secondary Outcome Measures

Retinal Thickening [11 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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