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
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intraocular Pressure
Intervention: Xibrom (Drug); Nevanac (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Bp Consulting, Inc Official(s) and/or principal investigator(s):
Nate Kleinfeldt, M.D, Principal Investigator, Affiliation: Coburn-Kleinfeldt Eye Clinic
Overall contact:
Michelle Chabot, Phone: 714-246-9581, Email: michelle_bpconsulting@yahoo.com
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: Treatment, Non-Randomized, Open Label, Crossover Assignment
Primary outcome: Tolerability of study medication
Secondary outcome: Intraocular pressure changesVisual 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
Michelle Chabot, Phone: 714-246-9581, Email: michelle_bpconsulting@yahoo.com
Coburn-Kleinfeldt Eye Clinic, 3340 6 mile Rd Livonia, Michigan 48152, United States
Additional Information
Starting date: January 2009
Ending date: December 2009
Last updated: January 23, 2009
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