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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.
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
History of Changes
  Purpose

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: 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:

U.S. FDA Resources

Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • Tolerability of study medication [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intraocular pressure changes [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Visual Acuity [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Nate Kleinfeldt, Coburn-Kleinfeldt Eye Clinic
ClinicalTrials.gov Identifier: NCT00828477     History of Changes
Other Study ID Numbers: 2009-0144
Study First Received: January 14, 2009
Last Updated: June 8, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bromfenac
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013