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NCT00025818 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00025818
Other study ID # 192371-011-01
Secondary ID
Status Completed
Phase Phase 3
First received October 26, 2001
Last updated May 27, 2011
Start date May 2001
Est. completion date March 2003

Study information
Verified date May 2011
Source Allergan
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 290
Est. completion date March 2003
Est. primary completion date March 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Ophthalmic Emulsion

Locations
Country Name City State
United States Cornea Consultants of Albany Albany New York
United States Emory University Atlanta Georgia
United States Dr. Freedman's Office Brooklyn New York
United States UIC Eye Center Chicago Illinois
United States The Cole Eye Institute Cleveland Ohio
United States Corona Research El Paso Texas
United States Baylor College of Medicine Houston Texas
United States Indiana University Indianapolis Indiana
United States Eyecare of La Jolla La Jolla California
United States D'Ambrosio Eye Care Leominster Massachusetts
United States UCLA Los Angeles California
United States Hunkleler Eye Center Overland Park Kansas
United States Northwest Cornea Portland Oregon
United States Great Lakes Eye Institute Saginaw Michigan
United States Dr. Wittpen's Office Stony Brook New York
United States Brandon Eye Clinic Tampa Florida
United States Opticare Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

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