Dry Eye
Conditions
Brief summary
This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.
Interventions
OTHERArtificial Tears
Artificial tears (any brand) may be used to treat dry eye symptoms.
Sponsors
Allergan
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients with Progression of Dry Eye Disease | Baseline, 60 Months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed