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

Primary Purpose

Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ophthalmic Emulsion
Sponsored by
Allergan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring dry eyes, rheumatoid arthritis, Lupus, Sjogren's syndrome, myositis, scleroderma, autoimmune disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eyecare of La Jolla
  • UCLA
  • Opticare
  • Brandon Eye Clinic
  • Emory University
  • UIC Eye Center
  • Indiana University
  • Hunkleler Eye Center
  • D'Ambrosio Eye Care
  • Great Lakes Eye Institute
  • Cornea Consultants of Albany
  • Dr. Freedman's Office
  • Dr. Wittpen's Office
  • The Cole Eye Institute
  • Northwest Cornea
  • Corona Research
  • Baylor College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 26, 2001
Last Updated
May 27, 2011
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00025818
Brief Title
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
March 2003 (Actual)
Study Completion Date
March 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Allergan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Scleroderma, Systemic
Keywords
dry eyes, rheumatoid arthritis, Lupus, Sjogren's syndrome, myositis, scleroderma, autoimmune disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ophthalmic Emulsion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Eyecare of La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Opticare
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Brandon Eye Clinic
City
Tampa
State/Province
Florida
ZIP/Postal Code
33629
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
UIC Eye Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Hunkleler Eye Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
D'Ambrosio Eye Care
City
Leominster
State/Province
Massachusetts
ZIP/Postal Code
01453
Country
United States
Facility Name
Great Lakes Eye Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48604
Country
United States
Facility Name
Cornea Consultants of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Dr. Freedman's Office
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Dr. Wittpen's Office
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Facility Name
The Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Northwest Cornea
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
Corona Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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

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