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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

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

U.S. FDA Resources

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
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.
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

No publications provided

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

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Prednisolone acetate
Methylprednisolone acetate
Bromfenac
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents

Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012