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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00828477
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : June 10, 2009
Information provided by:
Bp Consulting, Inc

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

Condition or disease Intervention/treatment Phase
Intraocular Pressure Drug: Xibrom Drug: Nevanac Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : January 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Xibrom (bromfenac)
Drug: Xibrom
Xibrom: two times a day for seven days in the first eye.
Other Name: bromfenac

Active Comparator: 2
Nevanac (nepafenac)
Drug: Nevanac
Nevanac: three times a day for seven days in the second eye.
Other Name: nepafenac

Primary Outcome Measures :
  1. Tolerability of study medication [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Intraocular pressure changes [ Time Frame: 28 days ]
  2. Visual Acuity [ Time Frame: 28 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00828477

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United States, Michigan
Coburn-Kleinfeldt Eye Clinic
3340 6 mile Rd Livonia, Michigan, United States, 48152
Sponsors and Collaborators
Bp Consulting, Inc
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Principal Investigator: Nate Kleinfeldt, M.D Coburn-Kleinfeldt Eye Clinic

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Responsible Party: Nate Kleinfeldt, Coburn-Kleinfeldt Eye Clinic Identifier: NCT00828477    
Other Study ID Numbers: 2009-0144
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: June 10, 2009
Last Verified: June 2009
Additional relevant MeSH terms:
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Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents