Nepafenac Opthalmic Suspension 0.1% Compared to Acular LS for Treatment of Inflammation After Cataract Surgery
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cataract
Intervention: Nepafenac Ophthalmic Suspension, 0.1% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s):
Andrew Maxwell, Study Director, Affiliation: Study Director
Summary
The purpose of this study is to compare the effectiveness of Nepafenac Ophthalmic Suspension,
0. 1% eye drops to Acular LS eye drops, used before and after cataract surgery, for treating
inflammation in the eye.
Clinical Details
Official title: Preoperative and Postoperative Nevanac 0.1% Compared to Acular LS for the Treatment of Ocular Inflammation Associated With Cataract Surgery
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of patients who are a clinical success at Day 14 postoperative visit (where a "clinical success" is defined as aqueous cells < grade 1 and aqueous flare = grade 0 at the current visit and all subsequent visits).
Secondary outcome: Percentage of patients who are clinically cured, clinical successes, treatment failure, clinically significant inflammation
Eligibility
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- planned cataract extraction with posterior chamber intraocular lens implantation
Exclusion Criteria:
- Under 10
Locations and Contacts
Lehmann Eye Center, Nacogdoches, Texas 76134, United States
Additional Information
Starting date: September 2005
Last updated: September 10, 2007
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