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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Intraocular Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Xibrom (bromfenac)

Group Type ACTIVE_COMPARATOR

Xibrom

Intervention Type DRUG

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

2

Nevanac (nepafenac)

Group Type ACTIVE_COMPARATOR

Nevanac

Intervention Type DRUG

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

Interventions

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Xibrom

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

Intervention Type DRUG

Nevanac

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

Intervention Type DRUG

Other Intervention Names

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bromfenac nepafenac

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes