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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00469781

Enrollment

Registered

2007-05-07

Start date

2007-05-31

Completion date

2008-09-30

Last updated

2008-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystoid Macular Edema,, Retinal Thickening

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.

Interventions

DRUG2. 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.

DRUG1. 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Cystoid Macular Edema	11 months

Secondary

Measure	Time frame
Retinal Thickening	11 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026