Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome - Full Text View

Purpose

A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune disorder AND/OR females 65 years of age or older.

Condition	Intervention	Phase
Keratoconjunctivitis Sicca Sjogren's Syndrome Lupus Erythematosus, Systemic Arthritis, Rheumatoid Scleroderma, Systemic	Drug: Ophthalmic Emulsion	Phase III

MedlinePlus related topics:

Autoimmune Diseases Lupus Rheumatoid Arthritis Scleroderma Sjogren's Syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Estimated Enrollment:	270
Study Start Date:	April 2001
Estimated Study Completion Date:	May 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Eighteen years or older
Diagnosis of moderate to severe dry eyes for at least 6 months and meet one or all of the following criteria:
Diagnosis of autoimmune disorder
Female 65 years of age or older

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00025818

Locations


United States, California
	Eyecare of La Jolla
	La Jolla, California, United States, 92037
	UCLA
	Los Angeles, California, United States, 90095

United States, Connecticut
	Opticare
	Waterbury, Connecticut, United States, 06708

United States, Florida
	Brandon Eye Clinic
	Tampa, Florida, United States, 33629

United States, Georgia
	Emory University
	Atlanta, Georgia, United States, 30322

United States, Illinois
	UIC Eye Center
	Chicago, Illinois, United States, 60612

United States, Indiana
	Indiana University
	Indianapolis, Indiana, United States, 46202

United States, Kansas
	Hunkleler Eye Center
	Overland Park, Kansas, United States, 66211

United States, Massachusetts
	D'Ambrosio Eye Care
	Leominster, Massachusetts, United States, 01453

United States, Michigan
	Great Lakes Eye Institute
	Saginaw, Michigan, United States, 48604

United States, New York
	Cornea Consultants of Albany
	Albany, New York, United States, 12159
	Dr. Freedman's Office
	Brooklyn, New York, United States, 11201
	Dr. Wittpen's Office
	Stony Brook, New York, United States, 11790

United States, Ohio
	The Cole Eye Institute
	Cleveland, Ohio, United States, 44195

United States, Oregon
	Northwest Cornea
	Portland, Oregon, United States, 97223

United States, Texas
	Baylor College of Medicine
	Houston, Texas, United States, 77030
	Corona Research
	El Paso, Texas, United States, 79903

Sponsors and Collaborators

Allergan

More Information

Study ID Numbers:	192371-011-01
First Received:	October 26, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00025818
Health Authority:	United States: Food and Drug Administration

Keywords provided by Allergan:

dry eyes

rheumatoid arthritis

Lupus

Sjogren's syndrome

myositis

scleroderma

autoimmune disorder

Study placed in the following topic categories:

Mouth Diseases

Arthritis, Rheumatoid

Lacrimal Apparatus Diseases

Dry Eye Syndromes

Myositis

Musculoskeletal Diseases

Lupus Erythematosus, Systemic

Arthritis

Connective Tissue Diseases

Idiopathic myopathy

Salivary Gland Diseases

Keratoconjunctivitis Sicca

Corneal Diseases

Autoimmune Diseases

Skin Diseases

Keratoconjunctivitis sicca

Joint Diseases

Eye Diseases

Rheumatic Diseases

Conjunctivitis

Keratoconjunctivitis

Conjunctival Diseases

Xerostomia

Xerophthalmia

Sjogren's Syndrome

Keratitis

Scleroderma, Systemic

Stomatognathic Diseases

Additional relevant MeSH terms:

Pathologic Processes

Disease

Immune System Diseases

Syndrome

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00025818