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

This study has been completed.
Sponsor:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00828477
First received: January 14, 2009
Last updated: June 8, 2009
Last verified: June 2009

January 14, 2009
June 8, 2009
January 2009
June 2009   (final data collection date for primary outcome measure)
Tolerability of study medication [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00828477 on ClinicalTrials.gov Archive Site
  • Intraocular pressure changes [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Visual Acuity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)
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)

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

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Intraocular Pressure
  • Drug: Xibrom
    Xibrom: two times a day for seven days in the first eye.
    Other Name: bromfenac
  • Drug: Nevanac
    Nevanac: three times a day for seven days in the second eye.
    Other Name: nepafenac
  • Active Comparator: 1
    Xibrom (bromfenac)
    Intervention: Drug: Xibrom
  • Active Comparator: 2
    Nevanac (nepafenac)
    Intervention: Drug: Nevanac
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00828477
2009-0144
No
Nate Kleinfeldt, Coburn-Kleinfeldt Eye Clinic
Bp Consulting, Inc
Not Provided
Principal Investigator: Nate Kleinfeldt, M.D Coburn-Kleinfeldt Eye Clinic
Bp Consulting, Inc
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP