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OpenTrials
Completed

NCT Number: NCT00828477

Evaluation of Comfort With Xibrom (Bromfenac Ophthalmic Solution)0.09% and Nevanac (Nepafenac Ophthalmic Suspension) 0.1% Following Selective Laser Trabeculoplasty (SLT)

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

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Key information

Conditions

Intraocular Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Coburn-Kleinfeldt Eye Clinic

3340 6 Mile Rd Livonia, Michigan, 48152, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xibrom

Drug

Xibrom: two times a day for seven days in the first eye.

Other names: bromfenac

Nevanac

Drug

Nevanac: three times a day for seven days in the second eye.

Other names: nepafenac

Primary outcomes

  1. Tolerability of study medication

    Time frame: 28 days

Secondary outcomes

  1. Intraocular pressure changes

    Time frame: 28 days

  2. Visual Acuity

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Bp Consulting, Inc

Network

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 26, 2009
Registry last updated
Jun 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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