Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)

Overview

The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Full Title of Study: “Evaluation of Comfort With the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Xibrom (Bromfenac Ophthalmic Solution) 0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2009

Detailed Description

Open label, single armed, cross over controlled study to evaluate comfort and IOP (Intraocular Pressure) changes of specific NSAIDs post SLT. Patients (n= 25, total 50 eyes) scheduled to undergo bilateral Selective Laser Trabeculoplasty (SLT) will instill bromfenac in the first eye to undergo SLT, and the contra lateral eye will receive nepafenac.

Interventions

  • Drug: Xibrom
    • Xibrom: two times a day for seven days in the first eye.
  • Drug: Nevanac
    • Nevanac: three times a day for seven days in the second eye.

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Xibrom (bromfenac)
  • Active Comparator: 2
    • Nevanac (nepafenac)

Clinical Trial Outcome Measures

Primary Measures

  • Tolerability of study medication
    • Time Frame: 28 days

Secondary Measures

  • Intraocular pressure changes
    • Time Frame: 28 days
  • Visual Acuity
    • Time Frame: 28 days

Participating in This Clinical Trial

Inclusion Criteria

  • > 18 years old, either gender or any race. – Diagnosis of open-angle glaucoma or ocular hypertension requiring laser trabeculoplasty. – Completion of written and informed consent/authorization prior to any study related procedures. – Able to follow study protocol and likely to complete study schedule. Exclusion Criteria:

  • Known sensitivity to NSAIDs. – History of neovascular or ocular inflammatory disease. – Current use of topical or systemic anti-inflammatory medications. – Females of childbearing potential.

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
    • Nate Kleinfeldt, Coburn-Kleinfeldt Eye Clinic
  • Overall Official(s)
    • Nate Kleinfeldt, M.D, Principal Investigator, Coburn-Kleinfeldt Eye Clinic

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