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

Sponsor

Bp Consulting, Inc (Other)

Overall Status

Completed

CT.gov ID

NCT00698724

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Drug: Xibrom, and Optive Drug: Xibrom and Pred Forte	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 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.
Active Comparator: 2 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.

Arm

Intervention/Treatment

Active Comparator: 1

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.

Active Comparator: 2

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.

Outcome Measures

Primary Outcome Measures

OCT [2-4 months]

Secondary Outcome Measures

Visual Acuity [2-4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

o 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)