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

May 27, 2011 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • Eyecare of La Jolla
      • Los Angeles, California, United States, 90095
        • UCLA
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Opticare
    • Florida
      • Tampa, Florida, United States, 33629
        • Brandon Eye Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • UIC Eye Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Hunkleler Eye Center
    • Massachusetts
      • Leominster, Massachusetts, United States, 01453
        • D'Ambrosio Eye Care
    • Michigan
      • Saginaw, Michigan, United States, 48604
        • Great Lakes Eye Institute
    • New York
      • Albany, New York, United States, 12159
        • Cornea Consultants of Albany
      • Brooklyn, New York, United States, 11201
        • Dr. Freedman's Office
      • Stony Brook, New York, United States, 11790
        • Dr. Wittpen's Office
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cole Eye Institute
    • Oregon
      • Portland, Oregon, United States, 97223
        • Northwest Cornea
    • Texas
      • El Paso, Texas, United States, 79903
        • Corona Research
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2001

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

October 26, 2001

First Submitted That Met QC Criteria

October 26, 2001

First Posted (Estimate)

October 29, 2001

Study Record Updates

Last Update Posted (Estimate)

May 30, 2011

Last Update Submitted That Met QC Criteria

May 27, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192371-011-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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