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 - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 13, 2008

Last Updated Date

March 31, 2009

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00698724 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind (Investigator), Parallel Assignment

Condition ^†

Cataracts

Intervention ^†

Drug: Xibrom, and Optive
Drug: Xibrom and Pred Forte

Study Arms / Comparison Groups

Active Comparator: Group 1: Xibrom, Optive
Active Comparator: Group 2: Xibrom, Pred Forte

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

200

Completion Date

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility 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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Michelle Chabot

714-246-9581

michelle_bpconsulting@yahoo.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698724

Responsible Party

Dr. Gills, St. Luke's Cataract and Laser Institute

Secondary IDs ^††

Study Sponsor ^†

Bp Consulting, Inc

Collaborators ^††

Investigators ^†

Principal Investigator:

James Gills, MD

St. Luke's Cataract and Laser Institute

Information Provided By

Bp Consulting, Inc

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.