A Natural History Study of Patients With Dry Eye
- Conditions
- Dry Eye
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 284
- 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)
- 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
- 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
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
Scroll for more (7 remaining)Jones Eye Institute🇺🇸Little Rock, Arkansas, United States