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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00025818
First received: October 26, 2001
Last updated: May 27, 2011
Last verified: May 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Enrollment: 290
Study Start Date: May 2001
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Corona Research
El Paso, Texas, United States, 79903
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Allergan
  More Information

No publications provided

Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00025818     History of Changes
Other Study ID Numbers: 192371-011-01
Study First Received: October 26, 2001
Last Updated: May 27, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 23, 2014