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Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00025818
Recruitment Status : Completed
First Posted : October 29, 2001
Last Update Posted : May 30, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Sjogren's Syndrome Lupus Erythematosus, Systemic Arthritis, Rheumatoid Scleroderma, Systemic Drug: Ophthalmic Emulsion Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : May 2001
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00025818

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United States, California
Eyecare of La Jolla
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90095
United States, Connecticut
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
Corona Research
El Paso, Texas, United States, 79903
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators

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Responsible Party: Therapeutic Area Head, Allergan, Inc Identifier: NCT00025818     History of Changes
Other Study ID Numbers: 192371-011-01
First Posted: October 29, 2001    Key Record Dates
Last Update Posted: May 30, 2011
Last Verified: May 2011

Keywords provided by Allergan:
dry eyes
rheumatoid arthritis
Sjogren's syndrome
autoimmune disorder

Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Sjogren's Syndrome
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Skin Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Conjunctival Diseases
Corneal Diseases