A Natural History Study of Patients With Dry Eye | NCT00833235 | Trialant
CompletedObservationalUpdated Jul 25, 2017
A Natural History Study of Patients With Dry Eye
ClinicalTrials.gov ID
NCT00833235
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
284Actual
Last Update Posted
Jul 25, 2017Actual
Start Date
Feb 1, 2009Actual
Primary Completion Date
Mar 6, 2017Actual
Completion Date
Mar 6, 2017Actual
Brief Summary
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
Dry Eye
Artificial Tears
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms
Baseline OSDI score of ≥ 13
Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)
Exclusion Criteria:
Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline
History of herpes keratitis or varicella zoster keratitis
Any history of allergic conjunctivitis
Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye
Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years
Patients with known systemic disease
Any history of corneal transplant
Observational Model
Case-Control
Time Perspective
Prospective
No central contacts
There are no central contacts for this study.
Jones Eye Institute
Little Rock, Arkansas 72205, United States
North Valley Eye Medical Group, Inc.
Mission Hills, California 91345, United States
Milauskas Eye Institute
Rancho Mirage, California 92270, United States
Eye Center of Northern Colorado
Fort Collins, Colorado 80525, United States
Cape Coral Eye Center, PA
Cape Coral, Florida 33904, United States
The Eye Institute of West Florida
Largo, Florida 33770, United States
The Wilmer Eye Institute Johns Hopkins Hospital
Baltimore, Maryland 21287, United States
Minnesota Eye Consultants, P.A.
Bloomington, Minnesota 55431, United States
Mulqueeny Eye Centers
Creve Coeur, Missouri 63141, United States
Mercy Eye Specilaists
Springfield, Missouri 65804, United States
Cleveland Eye Clinic
Brecksville, Ohio 44141, United States
Ophthalmic Partners Bala
Cynwyd, Pennsylvania 19004, United States
Hazleton Eye Specialists
Township, Pennsylvania 16066, United States
Vanderbilt Eye Institute
Nashville, Tennessee 37232, United States
Alkek Eye Center, Department of Ophthalmology
Houston, Texas 77030, United States
The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center