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

This study has been completed.

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

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




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