Nevanac 3-Month Safety Study With QID Dosing
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: Nevanac 0.1% Ophthalmic Suspension (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s): Stephen Lane, Study Director, Affiliation: Medical Monitor
Summary
The purpose of this protocol is to determine the safety of Nevanac 0. 1% compared to Acular LS
0. 4% and Vehicle in patients treated before cataract surgery and for approximately 90 days
following surgery.
Clinical Details
Official title: A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle Following Cataract Surgery
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Primary outcome: Macular thickness
Secondary outcome: contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters
Eligibility
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients of any race or sex ages 10 years or older undergoing cataract extraction with
planned implantation of a posterior chamber intraocular lens
Exclusion Criteria:
- Under 10
Locations and Contacts
Fort Worth - United States, Fort Worth, Texas 76134, United States
Additional Information
Starting date: February 2006
Last updated: September 19, 2007
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