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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)

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ClinicalTrials.gov Identifier: NCT00828477
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : June 10, 2009
Sponsor:
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.

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

MedlinePlus related topics: Eye Care
U.S. FDA Resources

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00828477


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

Responsible Party: Nate Kleinfeldt, Coburn-Kleinfeldt Eye Clinic
ClinicalTrials.gov Identifier: NCT00828477     History of Changes
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:
Ophthalmic Solutions
Nepafenac
Anti-Inflammatory Agents, Non-Steroidal
Bromfenac
Pharmaceutical Solutions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents