A Natural History Study of Patients With Dry Eye

Completed

• Conditions: Dry Eye
• Interventions: Other: Artificial Tears

• Registration Number: NCT00833235
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study Start: 2009-02-01
• Study First Posted: 2009-02-02
• Primary Completion: 2017-03-06
• Study Completion: 2017-03-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-22
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with dry eye	Artificial Tears	No treatment is prescribed for the study. Patient dry eye progression will be followed for up to 60 months. Patients may use artificial tears to treat their dry eye symptoms.
Patients with no history of dry eye	Artificial Tears	No treatment is prescribed for this control group. Patients will be followed for up to 60 months. If needed, patients may use artificial tears.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients with Progression of Dry Eye Disease	Baseline, 60 Months

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Ocular Surface Disease Index© (OSDI©) Score	Baseline, 60 Months
Percentage of Patients with an Increase in Blurred Vision	Baseline, 60 Months
Change from Baseline in Schirmer's Test	Baseline, 60 Months
Change from Baseline in Conjunctival Staining Score on a 6-Point Scale	Baseline, 60 Months
Change from Baseline in Corneal Staining Score on a 6-Point Scale	Baseline, 60 Months

Trial Locations

Locations (17)

Jones Eye Institute; 🇺🇸 Little Rock, Arkansas, United States

North Valley Eye Medical Group, Inc.; 🇺🇸 Mission Hills, California, United States

Eye Center of Northern Colorado; 🇺🇸 Fort Collins, Colorado, United States

Minnesota Eye Consultants, P.A.; 🇺🇸 Bloomington, Minnesota, United States

The Eye Institute of West Florida; 🇺🇸 Largo, Florida, United States

Cape Coral Eye Center, PA; 🇺🇸 Cape Coral, Florida, United States

Mulqueeny Eye Centers; 🇺🇸 Creve Coeur, Missouri, United States

See Clearly Vision Group; 🇺🇸 McLean, Virginia, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Hazleton Eye Specialists; 🇺🇸 Township, Pennsylvania, United States

Ophthalmic Partners Bala; 🇺🇸 Cynwyd, Pennsylvania, United States

The Eye Clinic of Texas/ dba Texas Clinical Eye Research Center; 🇺🇸 League City, Texas, United States

Vanderbilt Eye Institute; 🇺🇸 Nashville, Tennessee, United States

Alkek Eye Center, Department of Ophthalmology; 🇺🇸 Houston, Texas, United States

Milauskas Eye Institute; 🇺🇸 Rancho Mirage, California, United States

The Wilmer Eye Institute Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Mercy Eye Specilaists; 🇺🇸 Springfield, Missouri, United States