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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

Primary Purpose

Cataracts

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Xibrom, and Optive
Xibrom and Pred Forte
Sponsored by
Bp Consulting, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • St. Luke's Cataract and Laser institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Group 1: Xibrom, Optive

Group 2: Xibrom, Pred Forte

Outcomes

Primary Outcome Measures

OCT

Secondary Outcome Measures

Visual Acuity

Full Information

First Posted
June 13, 2008
Last Updated
June 8, 2009
Sponsor
Bp Consulting, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00698724
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bp Consulting, Inc

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Group 1: Xibrom, Optive
Arm Title
2
Arm Type
Active Comparator
Arm Description
Group 2: Xibrom, Pred Forte
Intervention Type
Drug
Intervention Name(s)
Xibrom, and Optive
Intervention Description
Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.
Intervention Type
Drug
Intervention Name(s)
Xibrom and Pred Forte
Intervention Description
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.
Primary Outcome Measure Information:
Title
OCT
Time Frame
2-4 months
Secondary Outcome Measure Information:
Title
Visual Acuity
Time Frame
2-4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Gills, MD
Organizational Affiliation
St. Luke's Cataract and Laser Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Cataract and Laser institute
City
Tarpon Springs
State/Province
Florida
ZIP/Postal Code
34688
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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