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

Tracking Information
First Received Date ^ICMJE	October 26, 2001
Last Updated Date	June 23, 2005
Start Date ^ICMJE	April 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00025818 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Keratoconjunctivitis Sicca Sjogren's Syndrome Lupus Erythematosus, Systemic Arthritis, Rheumatoid Scleroderma, Systemic
Intervention ^ICMJE	Drug: Ophthalmic Emulsion
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	270
Completion Date	May 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00025818
Responsible Party
Study ID Numbers ^ICMJE	192371-011-01
Study Sponsor ^ICMJE	Allergan
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Allergan
Verification Date	April 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP