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

Information source: Bp Consulting, Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Intraocular Pressure

Intervention: Xibrom (Drug); Nevanac (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Bp Consulting, Inc

Official(s) and/or principal investigator(s):
Nate Kleinfeldt, M.D, Principal Investigator, Affiliation: Coburn-Kleinfeldt Eye Clinic

Summary

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

Clinical Details

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)

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

Primary outcome: Tolerability of study medication

Secondary outcome:

Intraocular pressure changes

Visual Acuity

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Coburn-Kleinfeldt Eye Clinic, 3340 6 mile Rd Livonia, Michigan 48152, United States
Additional Information

Starting date: January 2009
Last updated: June 8, 2009

Page last updated: August 23, 2015

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