A Natural History Study of Patients With Dry Eye

Completed

Conditions studied: Dry Eye

In brief

This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.

Key facts

Study ID

NCT00833235

Run by

Allergan

People needed

284

Starts

2009-02-01

Expected to finish

2017-03-06

Last updated by the study team

2017-07-25

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Jones Eye Institute — Little Rock, Arkansas, United States
• North Valley Eye Medical Group, Inc. — Mission Hills, California, United States
• Milauskas Eye Institute — Rancho Mirage, California, United States
• Eye Center of Northern Colorado — Fort Collins, Colorado, United States
• Cape Coral Eye Center, PA — Cape Coral, Florida, United States
• The Eye Institute of West Florida — Largo, Florida, United States
• The Wilmer Eye Institute Johns Hopkins Hospital — Baltimore, Maryland, United States
• Minnesota Eye Consultants, P.A. — Bloomington, Minnesota, United States
• Mulqueeny Eye Centers — Creve Coeur, Missouri, United States
• Mercy Eye Specilaists — Springfield, Missouri, United States
• Cleveland Eye Clinic — Brecksville, Ohio, United States
• Ophthalmic Partners Bala — Cynwyd, Pennsylvania, United States
• Hazleton Eye Specialists — Township, Pennsylvania, United States
• Vanderbilt Eye Institute — Nashville, Tennessee, United States
• Alkek Eye Center, Department of Ophthalmology — Houston, Texas, United States
• The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center — League City, Texas, United States
• See Clearly Vision Group — McLean, Virginia, United States

Full record on ClinicalTrials.gov

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