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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

Page last updated: June 20, 2008

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