A Natural History Study of Patients With Dry Eye

Allergan

Status: Completed

Conditions: Dry Eye

Treatments: Other: Artificial Tears

Study type: Observational

Funder types: Industry

Identifiers

NCT00833235

MA-RES-08-001

Details and patient eligibility

About

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

Enrollment: 284 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

284 participants in 2 patient groups

Patients with dry eye

Description:

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.

Treatment:

Other: Artificial Tears

Patients with no history of dry eye

Description:

No treatment is prescribed for this control group. Patients will be followed for up to 60 months. If needed, patients may use artificial tears.

Treatment:

Other: Artificial Tears