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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Lupus Rheumatoid Arthritis Scleroderma Sjogren's Syndrome

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	192371-011-01
Study First Received:	October 26, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00025818 History of Changes
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
Lupus
Arthritis, Rheumatoid
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Myositis
Musculoskeletal Diseases
Lupus Erythematosus, Systemic
Sjogren Syndrome
Arthritis
Connective Tissue Diseases
Scleroderma
Salivary Gland Diseases
Keratoconjunctivitis Sicca
Corneal Diseases

Idiopathic Myopathy
Autoimmune Diseases
Skin Diseases
Joint Diseases
Eye Diseases
Rheumatic Diseases
Conjunctivitis
Keratoconjunctivitis
Conjunctival Diseases
Xerostomia
Xerophthalmia
Sjogren's Syndrome
Keratitis
Scleroderma, Systemic
Stomatognathic Diseases

Additional relevant MeSH terms:

Mouth Diseases
Arthritis, Rheumatoid
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Pathologic Processes
Musculoskeletal Diseases
Lupus Erythematosus, Systemic
Syndrome
Arthritis
Connective Tissue Diseases
Salivary Gland Diseases
Keratoconjunctivitis Sicca
Corneal Diseases
Autoimmune Diseases
Disease

Immune System Diseases
Skin Diseases
Joint Diseases
Eye Diseases
Rheumatic Diseases
Conjunctivitis
Keratoconjunctivitis
Xerostomia
Conjunctival Diseases
Xerophthalmia
Sjogren's Syndrome
Keratitis
Scleroderma, Systemic
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 06, 2009