Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00025818
Recruitment Status : Completed
First Posted : October 29, 2001
Last Update Posted : May 30, 2011
Sponsor:
Information provided by:
Allergan

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

Layout table for study information
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

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00025818


Locations
Show Show 17 study locations
Sponsors and Collaborators
Allergan
Layout table for additonal information
Responsible Party: Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier: NCT00025818    
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
Lupus
Sjogren's syndrome
myositis
scleroderma
autoimmune disorder
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Sjogren's Syndrome
Arthritis, Rheumatoid
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Scleroderma, Systemic
Scleroderma, Diffuse
Lupus Erythematosus, Systemic
Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Skin Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases