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Nevanac 3-Month Safety Study With QID Dosing

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Nepafenac ophthalmic solution 0.1% (Drug); Ketorolac Tromethamine ophthalmic solution 0.4% (Drug); Nepafenac ophthalmic suspension vehicle (Other)

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 study 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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Under 10

- Other protocol-defined exclusion criteria may apply

Locations and Contacts

Contact Alcon for Trial Locations, Fort Worth, Texas 76134, United States
Additional Information

Starting date: February 2006
Last updated: March 1, 2012

Page last updated: August 23, 2015

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