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

Bp Consulting

Status and phase: Completed; Phase 4

Conditions: Intraocular Pressure

Treatments: Drug: Xibrom; Drug: Nevanac

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT00828477

2009-0144

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

1

Active Comparator group

Description:

Xibrom (bromfenac)

Treatment:

Drug: Xibrom

2

Active Comparator group

Description:

Nevanac (nepafenac)

Treatment:

Drug: Nevanac