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

Sponsored by:	Center For Excellence In Eye Care
Information provided by:	Center For Excellence In Eye Care
ClinicalTrials.gov Identifier:	NCT00469781

Purpose

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	Intervention	Phase
Cystoid Macular Edema, Retinal Thickening	Drug: 2. Xibrom (Bromfenac) Drug: 1. Pred Forte	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Bromfenac Bromfenac sodium 16-Methyleneprednisolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment

Further study details as provided by Center For Excellence In Eye Care:

Primary Outcome Measures:

Cystoid Macular Edema [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Retinal Thickening [ Time Frame: 11 months ] [ Designated as safety issue: No ]

Enrollment:	95
Study Start Date:	May 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	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.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469781

Locations

United States, Florida
The Center for Excellence in Eye Care
Miami, Florida, United States, 33176

Sponsors and Collaborators

Center For Excellence In Eye Care

Investigators

Principal Investigator:

Carlos Buznego, MD

The Center for Excellence in Eye Care

More Information

Responsible Party:	The Center for Excellence in Eye Care ( Carlos Buznego, MD )
Study ID Numbers:	5306
Study First Received:	May 4, 2007
Last Updated:	September 23, 2008
ClinicalTrials.gov Identifier:	NCT00469781
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Methylprednisolone
Eye Diseases
Edema
Macular Degeneration
Retinal Degeneration
Methylprednisolone acetate
Prednisolone acetate

Macular Edema
Signs and Symptoms
Bromfenac
Prednisolone
Retinal Diseases
Retinal degeneration
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009