Status:
COMPLETED
A Natural History Study of Patients With Dry Eye
Lead Sponsor:
Allergan
Conditions:
Dry Eye
Eligibility:
All Genders
40+ years
Brief Summary
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 6 2017
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT00833235
Start Date
February 1 2009
End Date
March 6 2017
Last Update
July 25 2017
Active Locations (17)
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1
Jones Eye Institute
Little Rock, Arkansas, United States, 72205
2
North Valley Eye Medical Group, Inc.
Mission Hills, California, United States, 91345
3
Milauskas Eye Institute
Rancho Mirage, California, United States, 92270
4
Eye Center of Northern Colorado
Fort Collins, Colorado, United States, 80525