Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

This study has been completed.

First Received: June 13, 2008 Last Updated: June 8, 2009 History of Changes

Sponsored by:	Bp Consulting, Inc
Information provided by:	Bp Consulting, Inc
ClinicalTrials.gov Identifier:	NCT00698724

Purpose

To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.

Condition	Intervention	Phase
Cataracts	Drug: Xibrom, and Optive Drug: Xibrom and Pred Forte	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment
Official Title:	A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

Resource links provided by NLM:

MedlinePlus related topics: Cataract Surgery

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

U.S. FDA Resources

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:

OCT [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Visual Acuity [ Time Frame: 2-4 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	June 2008
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Group 1: Xibrom, Optive	Drug: Xibrom, and Optive Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.
2: Active Comparator Group 2: Xibrom, Pred Forte	Drug: Xibrom and Pred Forte Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female at least 18 years of age.
- Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively.
- Patients should be in good general health and devoid of recognized risk factors for CME.
- Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy)
- Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits
- Only one eye of each treated patient may be included in the study

Exclusion Criteria:

Any known contraindications to any study medication or their component
Presence of uncontrolled systemic disease
Required use of other ocular medications during the study
- Artificial tears may be used
Diabetics with any clinically evident or history of retinopathy
Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation
Abnormal pre-operative OCT (if obtainable)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698724

Locations

United States, Florida
St. Luke's Cataract and Laser institute
Tarpon Springs, Florida, United States, 34688

Sponsors and Collaborators

Bp Consulting, Inc

Investigators

Principal Investigator:

James Gills, MD

St. Luke's Cataract and Laser Institute

More Information

No publications provided

Responsible Party:	St. Luke's Cataract and Laser Institute ( Dr. Gills )
Study ID Numbers:	5359
Study First Received:	June 13, 2008
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00698724 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Methylprednisolone
Hormone Antagonists
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate
Lens Diseases
Prednisolone acetate
Neuroprotective Agents

Glucocorticoids
Hormones
Bromfenac
Analgesics, Non-Narcotic
Cataract
Prednisolone
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Lens Diseases
Hormones
Neuroprotective Agents
Sensory System Agents
Therapeutic Uses
Cataract
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Eye Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Glucocorticoids
Protective Agents
Pharmacologic Actions
Bromfenac
Analgesics, Non-Narcotic
Autonomic Agents
Prednisolone
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2009