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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2009

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • OCT
    • Time Frame: 2-4 months

Secondary Measures

  • Visual Acuity
    • Time Frame: 2-4 months

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bp Consulting, Inc
  • Provider of Information About this Clinical Study
    • Dr. Gills, St. Luke’s Cataract and Laser Institute
  • Overall Official(s)
    • James Gills, MD, Principal Investigator, St. Luke’s Cataract and Laser Institute

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