Volume 33, Issue 1 , Pages 53-58, January 2007
Nepafenac ophthalmic suspension 0.1% for the prevention and treatment of ocular inflammation associated with cataract surgery
Purpose
To determine whether nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation.
Setting
Twenty-one ophthalmology clinics in the United States.
Methods
A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score = 0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores.
Results
The mean age of the 476 patients (243 nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the nepafenac group and 40 (17.2%) in the vehicle group were cured (P<.0001). A higher percentage of patients in the nepafenac group was pain free at all visits (P<.0001). Throughout the study, most nepafenac-treated patients were pain free (83.1% to 93.0%) compared with less than half the vehicle-treated patients (41.6% to 46.4%). The nepafenac group had lower mean aqueous cells, flare, and cells plus flare scores at all visits (P<.0001). No treatment-related ocular adverse events occurred in either group.
Conclusion
Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.
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Presented at the ASCRS Symposium on Cataract, IOL and Refractive Surgery, Washington, D.C., USA, April 2005.Funded by Alcon Research, Ltd., Fort Worth, Texas, USA.No author has a financial or proprietary interest in any method or material mentioned.Louis M. Alpern, MD, Robert J. Arleo, MD, Stephen F. Brint, MD, Mike Caplan, MD, Lisa Marie Cibik, MD, Robert J. Cionni, MD, Peter S. Dawson, MD, Arthur M. Fishman, MD, Gary Foster, MD, Henry M. Haley Jr, MD, Jeffrey D. Horn, MD, Ronald A. Landry, MD, Matthew D. Paul, MD, E. Ronald Salvitti, MD, Stephen V. Scoper, MD, Steven Silverstein, MD, and Jeffrey C. Whitsett, MD, served as fellow investigators.
PII: S0886-3350(06)01213-2
doi:10.1016/j.jcrs.2006.08.043
© 2007 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.
Refers to erratum:
- Erratum
Volume 33, Issue 1 , Pages 53-58, January 2007