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.

First Received: January 14, 2009 Last Updated: June 8, 2009 History of Changes

Sponsored by:	Bp Consulting, Inc
Information provided by:	Bp Consulting, Inc
ClinicalTrials.gov Identifier:	NCT00828477

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment
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:

Drug Information available for: Nepafenac Bromfenac Bromfenac sodium

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
1: Active Comparator Xibrom (bromfenac)	Drug: Xibrom Xibrom: two times a day for seven days in the first eye.
2: Active Comparator Nevanac (nepafenac)	Drug: Nevanac Nevanac: three times a day for seven days in the second eye.

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bromfenac
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Bromfenac
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009