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

Phase 4
Completed
Conditions
Intraocular Pressure
Interventions
Registration Number
NCT00828477
Lead Sponsor
Bp Consulting, Inc
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
1XibromXibrom (bromfenac)
2NevanacNevanac (nepafenac)
Primary Outcome Measures
NameTimeMethod
Tolerability of study medication28 days
Secondary Outcome Measures
NameTimeMethod
Intraocular pressure changes28 days
Visual Acuity28 days

Trial Locations

Locations (1)

Coburn-Kleinfeldt Eye Clinic

🇺🇸

3340 6 mile Rd Livonia, Michigan, United States

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