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| Sponsor: | 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Contacts and 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 | |
More Information
| 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 |
|
dry eyes rheumatoid arthritis Lupus Sjogren's syndrome |
myositis scleroderma autoimmune disorder |
|
Arthritis Arthritis, Rheumatoid Scleroderma, Systemic Scleroderma, Diffuse Dry Eye Syndromes Keratoconjunctivitis Sicca Keratoconjunctivitis Lupus Erythematosus, Systemic Sjogren's Syndrome Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Skin Diseases Lacrimal Apparatus Diseases Eye Diseases Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases |
