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

Sponsor

Allergan (Industry)

Overall Status

Completed

CT.gov ID

NCT00025818

Collaborator

(none)

290

Enrollment

Locations

Duration (Months)

17.1

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconjunctivitis Sicca Sjogren's Syndrome Lupus Erythematosus, Systemic Arthritis, Rheumatoid Scleroderma, Systemic	Drug: Ophthalmic Emulsion	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

290 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

May 1, 2001

Actual Primary Completion Date :

Mar 1, 2003

Actual Study Completion Date :

Mar 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eyecare of La Jolla	La Jolla	California	United States	92037
2	UCLA	Los Angeles	California	United States	90095
3	Opticare	Waterbury	Connecticut	United States	06708
4	Brandon Eye Clinic	Tampa	Florida	United States	33629
5	Emory University	Atlanta	Georgia	United States	30322
6	UIC Eye Center	Chicago	Illinois	United States	60612
7	Indiana University	Indianapolis	Indiana	United States	46202
8	Hunkleler Eye Center	Overland Park	Kansas	United States	66211
9	D'Ambrosio Eye Care	Leominster	Massachusetts	United States	01453
10	Great Lakes Eye Institute	Saginaw	Michigan	United States	48604
11	Cornea Consultants of Albany	Albany	New York	United States	12159
12	Dr. Freedman's Office	Brooklyn	New York	United States	11201
13	Dr. Wittpen's Office	Stony Brook	New York	United States	11790
14	The Cole Eye Institute	Cleveland	Ohio	United States	44195
15	Northwest Cornea	Portland	Oregon	United States	97223
16	Corona Research	El Paso	Texas	United States	79903
17	Baylor College of Medicine	Houston	Texas	United States	77030