NCT00025818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2001

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 29, 2001

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

1.8 years

First QC Date

October 26, 2001

Last Update Submit

May 27, 2011

Conditions

Keywords

dry eyesrheumatoid arthritisLupusSjogren's syndromemyositissclerodermaautoimmune disorder

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (17)

Eyecare of La Jolla

La Jolla, California, 92037, United States

Location

UCLA

Los Angeles, California, 90095, United States

Location

Opticare

Waterbury, Connecticut, 06708, United States

Location

Brandon Eye Clinic

Tampa, Florida, 33629, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

UIC Eye Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Hunkleler Eye Center

Overland Park, Kansas, 66211, United States

Location

D'Ambrosio Eye Care

Leominster, Massachusetts, 01453, United States

Location

Great Lakes Eye Institute

Saginaw, Michigan, 48604, United States

Location

Cornea Consultants of Albany

Albany, New York, 12159, United States

Location

Dr. Freedman's Office

Brooklyn, New York, 11201, United States

Location

Dr. Wittpen's Office

Stony Brook, New York, 11790, United States

Location

The Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Northwest Cornea

Portland, Oregon, 97223, United States

Location

Corona Research

El Paso, Texas, 79903, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis SiccaSjogren's SyndromeLupus Erythematosus, SystemicArthritis, RheumatoidScleroderma, SystemicDry Eye SyndromesMyositisScleroderma, DiffuseAutoimmune Diseases

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesLacrimal Apparatus DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesSkin DiseasesMuscular DiseasesNeuromuscular DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 26, 2001

First Posted

October 29, 2001

Study Start

May 1, 2001

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

May 30, 2011

Record last verified: 2011-05

Locations