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

Intraocular Pressure Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00828477
• Other study ID #: 2009-0144
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2009
• Last updated: June 8, 2009
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

Drug:
• Xibrom
Xibrom: two times a day for seven days in the first eye.
• Nevanac
Nevanac: three times a day for seven days in the second eye.

Locations

Country	Name	City	State
United States	Coburn-Kleinfeldt Eye Clinic	3340 6 mile Rd Livonia	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bp Consulting, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of study medication		28 days	No
Secondary	Intraocular pressure changes		28 days	No
Secondary	Visual Acuity		28 days	No