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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)

This study has been completed.
Information provided by:
Bp Consulting, Inc Identifier:
First received: January 14, 2009
Last updated: June 8, 2009
Last verified: June 2009
The objective of this study is to evaluate and compare the comfort of bromfenac or nepafenac following SLT.

Condition Intervention Phase
Intraocular Pressure Drug: Xibrom Drug: Nevanac Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Bp Consulting, Inc:

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

Secondary Outcome Measures:
  • Intraocular pressure changes [ Time Frame: 28 days ]
  • Visual Acuity [ Time Frame: 28 days ]

Estimated Enrollment: 25
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00828477

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

Responsible Party: Nate Kleinfeldt, Coburn-Kleinfeldt Eye Clinic Identifier: NCT00828477     History of Changes
Other Study ID Numbers: 2009-0144
Study First Received: January 14, 2009
Last Updated: June 8, 2009

Additional relevant MeSH terms:
Ophthalmic Solutions
Anti-Inflammatory Agents, Non-Steroidal
Pharmaceutical Solutions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on September 19, 2017